Boston Scientific Corporation
234 product lines across 22 device categories: Ablation systems, Angioplasty balloons, Atherectomy, Biliary drains, Carotid stents, Angiographic catheters.
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Tumor Ablation Systems (Microwave, RF, Cryo)
Used in: Liver Tumor Ablation (Microwave or Radiofrequency), Kidney Tumor Ablation (Cryoablation or Microwave)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Visual-ICE MRI Visual-ICE™ MRI Mobile Connection Panel Spare | — | 9 | MR Conditional |
| IceSeed Cryoablation Needle | Shaft Length: 100–175 mm; Length: 175 mm; Needle Gauge: 17 G | 3 | MR Unsafe |
| Multi-Point 1.5 Thermal Sensor 1.5mm Multi-Point Thermal Sensor Cryoablation Needle | — | 1 | MR Unsafe |
| IceSeed 1.5 MRI Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Conditional |
| IcePearl 2.1 CX 90° Cryoablation Needle 2.1mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| Three IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template | — | 1 | MR Unsafe |
| Visual-ICE Cryoablation System - Evaluation Cryoablation System | — | 1 | MR Unsafe |
| IceSeed 1.5 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| Visual-ICE Cryoablation System - Zero Cost Cryoablation System | — | 1 | MR Unsafe |
| IceRod i-Thaw Prostate Cryoablation Kit / Visual-ICE System Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template | — | 1 | MR Unsafe |
| Visual-ICE Cryoablation System - Customer Owned Cryoablation System | — | 1 | MR Unsafe |
| ICEfx Cryoablation System Cart Cryoablation System Accessory | — | 1 | MR Unsafe |
| IceSeed 1.5 MRI 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Conditional |
| IceRod 1.5 MRI 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Conditional |
| IceRod 1.5 CX 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| IceRod 1.5 i-Thaw Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Unsafe |
| ICEfx Cryoablation System - Zero Cost Cryoablation System | — | 1 | MR Unsafe |
| IceFORCE 2.1 CX 90° Cryoablation Needle 2.1mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| IcePearl 2.1 CX Prostate Cryoablation Kit / Visual-ICE System Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template | — | 1 | MR Unsafe |
| IceRod 1.5 PLUS Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Unsafe |
| Galil Medical Urethral Warming Set Set of disposable components used in conjunction with a warmer system and peristaltic pump, is intended to warm urethral tissue when performing… | — | 1 | MR Unsafe |
| IceRod 1.5 PLUS 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| IcePearl 2.1 CX L 90° Cryoablation Needle 2.1 mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| IceFORCE 2.1 CX Prostate Cryoablation Kit / Visual-ICE System Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template | — | 1 | MR Unsafe |
| IceSeed 1.5 Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Unsafe |
| Visual-ICE Cryoablation System Cryoablation System | — | 1 | MR Unsafe |
| IceSphere 1.5 CX Cryoablation Needle 1.5 mm Cryoablation Needle | Outer Diameter: 1.5 mm; Shaft Length: 175 mm | 1 | MR Unsafe |
| IcePearl 2.1 CX Cryoablation Needle 2.1mm Cryoablation Needle | — | 1 | MR Unsafe |
| EZ CONNECT2 Dual Cylinder Adapter, psi Visual-ICE Cryoablation System Accessory | Length: 5 m | 1 | MR Unsafe |
| IceSphere 1.5 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| Three IcePearl 2.1 CX Prostate Cryoablation KitVisual-ICE System Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template | — | 1 | MR Unsafe |
| IceSphere Cryoablation Needle | Length: 175 mm; Needle Gauge: 17 G | 1 | MR Unsafe |
| ICEfx Cryoablation System Cryoablation System | — | 1 | MR Unsafe |
| IceSphere 1.5 S 90° Cryoablation Needle 1.5mm 90 degree Cryoablation Needle | — | 1 | MR Unsafe |
| ICEfx Cryoablation System - Customer Owned Cryoablation System | — | 1 | MR Unsafe |
| IceRod 1.5 MRI Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Conditional |
| IceRod Cryoablation Needle | Needle Gauge: 17 G; Length: 175 mm | 1 | MR Unsafe |
| IceRod 1.5 Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Unsafe |
| IceFORCE 2.1 CX L 90° Cryoablation Needle | — | 1 | MR Unsafe |
| IceFORCE 2.1 CX Cryoablation Needle 2.1mm Cryoablation Needle | — | 1 | MR Unsafe |
| ICEfx Cryoablation System - Evaluation Cryoablation System | — | 1 | MR Unsafe |
| ICEfx Cryoablation System - Refurbished Cryoablation System | — | 1 | MR Unsafe |
| IceSeed Prostate Cryoablation Kit / Presice System Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template | — | 1 | MR Unsafe |
| Visual-ICE Cryoablation System - Refurbished Cryoablation System | — | 1 | MR Unsafe |
| IceSphere 1.5 Cryoablation Needle 1.5mm Cryoablation Needle | — | 1 | MR Unsafe |
Peripheral Angioplasty Balloons
Used in: DVT Mechanical Thrombectomy, Venous Stenting (Iliac and Central Veins), Peripheral Balloon Angioplasty, Peripheral Artery Stenting, Peripheral Atherectomy, Fistulogram with Angioplasty
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| MUSTANG PTA Balloon Dilatation Catheter | — | 203 | Not stated |
| Sterling PTA Balloon Dilatation Catheter | Balloon Length: 40–200 mm; Length: 200 cm; Balloon Diameter: 4–7 mm | 185 | Not stated |
| Charger PTA Balloon Dilatation Catheter | — | 109 | Not stated |
| Gladiator Elite PTA Balloon Dilatation Catheter | — | 102 | Not stated |
| Athletis PTA Balloon Dilatation Catheter | Catheter Length: 50–135 cm; Balloon Length: 20–100 mm; Balloon Diameter: 4–12 mm | 76 | Not stated |
| Symmetry Stiff Shaft Balloon Dilatation Catheter | — | 71 | Not stated |
| Coyote PTA Balloon Dilatation Catheter | — | 62 | Not stated |
| Symmetry Balloon Dilatation Catheter | — | 51 | Not stated |
| Sterling SL PTA Balloon Dilatation Catheter | — | 40 | Not stated |
| Coyote ES PTA Balloon Dilatation Catheter | — | 32 | Not stated |
| XXL Vascular Balloon Dilatation Catheter | — | 10 | Not stated |
Atherectomy Devices
Used in: Peripheral Atherectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Peripheral RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device | — | 8 | Not stated |
| Peripheral ROTAPRO Rotational Atherectomy Device | Atherectomy Rotating Component Diameter: 1.25–2.5 mm | 8 | Not stated |
| JETSTREAM PVCN100 Console | — | 3 | Not stated |
| JETSTREAM XC Atherectomy Catheter | — | 2 | Not stated |
| Rotaglide Lubricant | — | 2 | Not stated |
| Rotablator Rotational Atherectomy System Console Kit Rotational Atherectomy System | — | 2 | Not stated |
| JETSTREAM SC Atherectomy Catheter | — | 2 | Not stated |
| Rotablator Dynaglide™ Foot Pedal | — | 1 | Not stated |
Biliary Drainage Catheters
Used in: Percutaneous Biliary Drainage (PTBD)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Advanix Biliary Biliary Stent | — | 84 | MR Safe |
| Flexima Biliary Catheter System with Radiopaque Marker | — | 27 | Not stated |
| WallFlex Biliary Stent System | Stent Length: 100 mm; Stent Diameter: 8–10 mm | 22 | MR Conditional |
| Flexima Biliary Biliary Stent with Delivery System | — | 20 | MR Safe |
| Percuflex Biliary Biliary Stent | — | 20 | MR Safe |
| RX Biliary Biliary Stent with RX Delivery System | — | 20 | MR Safe |
| WallFlex Biliary Transhepatic Stent System | — | 18 | MR Conditional |
| Express SD Renal/Biliary Premounted Stent System | — | 16 | MR Conditional |
| WALLSTENT RX BILIARY RX Biliary Endoprosthesis Stent System | — | 14 | MR Conditional |
| Expel Drainage Catheter with Twist-Loc Hub MPDL Drainage Catheter | — | 13 | MR Conditional |
| CRE PRO Esophageal/Pyloric/Colonic/Biliary Wireguided Balloon Dilatation Catheter | — | 12 | Not stated |
| WALLSTENT BILIARY Endoscopic Biliary Endoprosthesis | — | 12 | MR Conditional |
| Epic Biliary Stent System | — | 12 | MR Conditional |
| CRE RX Biliary Balloon Dilatation Catheter | — | 9 | Not stated |
| Express LD Biliary Premounted Stent System | — | 8 | MR Conditional |
| Hurricane RX Balloon Dilatation Catheter | — | 8 | Not stated |
| WallFlex Stent System | Stent Diameter: 8–10 mm; Stent Length: 40–100 mm | 7 | MR Conditional |
| Flexima Nasobiliary Catheter Kit Nasobiliary Catheter with Guidewire | — | 7 | MR Safe |
| C-Flex Biliary Biliary Stent | — | 6 | MR Safe |
| MaxForce Balloon Dilatation Catheter | — | 6 | Not stated |
| Expel Drainage Catheter MPD Drainage Catheter | — | 5 | MR Conditional |
| Expel Large Capacity Drainage Catheter MPD Large Capacity Drainage Catheter | — | 4 | MR Conditional |
| Flexima Nasobiliary Catheter Nasobiliary Catheter | — | 4 | MR Safe |
| vanSonnenberg Sump Sump Catheter System | — | 4 | Not stated |
| WALLSTENT RP Endoprosthesis Self-Expanding Stent | — | 4 | MR Conditional |
| APDL Drainage Catheter System | — | 3 | Not stated |
| NaviFlex RX Delivery System RX Delivery System | — | 3 | Not stated |
| vanSonnenberg Drainage Catheter System | — | 2 | Not stated |
| Biliary Stent Introducer | — | 2 | Not stated |
| Amplatz Anchor Amplatz Anchor Catheter System | — | 1 | Not stated |
| NA Flexible Stiffener | — | 1 | Not stated |
Carotid Stents
Used in: Carotid Artery Stenting
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Carotid WALLSTENT Closed Cell Self-Expanding Stent | — | 7 | MR Conditional |
Angiographic Catheters
Used in: Uterine Artery Embolization (UAE), Internal Iliac Artery Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Expo Angiographic Catheter | — | 180 | Not stated |
| Impulse Angiographic Catheter | — | 158 | Not stated |
| IMAGER II Angiographic Catheter | — | 145 | Not stated |
Drug-Coated Balloons
Used in: Peripheral Balloon Angioplasty, Peripheral Atherectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Ranger Paclitaxel-Coated PTA Balloon Catheter | Balloon Length: 30–200 mm; Balloon Diameter: 4–8 mm; Catheter Length: 80–150 cm | 100 | Not stated |
Embolic Protection Devices
Used in: Carotid Artery Stenting
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| FilterWire EZ Embolic Protection System | — | 4 | Not stated |
| EZ Bent Tip Retrieval Sheath | — | 1 | Not stated |
| ENROUTE Transcarotid Neuroprotection System | — | 1 | Not stated |
Embolization Coils
Used in: Uterine Artery Embolization (UAE), Prostate Artery Embolization (PAE), Ovarian Vein Embolization, Varicocele Embolization, Portal Vein Embolization, TIPS (Transjugular Intrahepatic Portosystemic Shunt)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Interlock-35 Fibered IDC™ Occlusion System | — | 36 | MR Conditional |
| Interlock Fibered IDC™ Occlusion System | — | 26 | MR Conditional |
| EMBOLD Fibered Detachable Coil System | Outer Diameter: 2–32 mm; Length: 4–60 cm | 24 | MR Conditional |
| EMBOLD Soft Detachable Coil System | Outer Diameter: 2–8 mm; Length: 2–60 cm | 22 | MR Conditional |
| IDC Interlocking Detachable Coil | — | 9 | MR Conditional |
| 2D Helical - 35 Fibered Platinum Coil | — | 8 | MR Conditional |
| Complex Helical - 18 Fibered Platinum Coil | — | 6 | MR Conditional |
| VortX Diamond - 18 Fibered Platinum Coil | — | 4 | MR Conditional |
| VortX - 18 Fibered Platinum Coil | — | 4 | MR Conditional |
| VortX - 35 VORTX 35 FIBERED COIL 3MM-7MM (1) | — | 4 | MR Conditional |
| EMBOLD Packing Detachable Coil System | Length: 15–60 cm | 4 | MR Conditional |
| Straight - 18 Fibered Platinum Coil | — | 2 | MR Conditional |
| Multi-Loop - 18 Fibered Platinum Coil | — | 1 | MR Conditional |
| Coil Pusher-16 | — | 1 | Not stated |
| Figure 8 - 18 Fibered Platinum Coil | — | 1 | MR Conditional |
Embolic Microspheres and Particles (Beads)
Used in: Uterine Artery Embolization (UAE), Prostate Artery Embolization (PAE), Genicular Artery Embolization (GAE), Transarterial Chemoembolization (TACE), Portal Vein Embolization, Middle Meningeal Artery Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Embozene Microspheres for Embolization | — | 20 | MR Safe |
| Contour Embolization Particles | — | 14 | Not stated |
| ONCOZENE Microspheres for Embolization | — | 6 | MR Safe |
| Bead Block Bland Embolic Bead | — | 5 | MR Safe |
| LC Bead 300-500 Embolic spheres | — | 1 | MR Safe |
| Bead Block 500-700 Embolic spheres. | — | 1 | Not stated |
| Bead Block 300-500 Embolization spheres | — | 1 | Not stated |
| LC Bead 100-300 Embolic spheres | — | 1 | MR Safe |
| LC Bead LUMI 70 - 150 Embolic spheres | — | 1 | Not stated |
| Bead Block 100-300 Embolization spheres | — | 1 | Not stated |
| LC Bead M1 70-150 Embolic spheres | — | 1 | MR Safe |
| LC Bead LUMI 40 - 90 Embolic spheres | — | 1 | Not stated |
| Bead Block 700-900 Embolic spheres | — | 1 | Not stated |
| Bead Block 900-1200 Embolic spheres | — | 1 | Not stated |
Gastrostomy and GJ Tubes
Used in: Gastrostomy (G-Tube) Placement, Gastrojejunostomy (GJ-Tube) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| EndoVive One Step Button Low Profile Percutaneous Endoscopic Gastrostomy Kit | — | 36 | Not stated |
| EndoVive Button Decompression Tube Low Profile Button Decompression Tube | — | 18 | Not stated |
| EndoVive Low Profile Replacement Button Low Profile Replacement Gastrostomy Tube | — | 18 | Not stated |
| EndoVive Standard PEG Kit Percutaneous Endoscopic Gastrostomy Kit | — | 8 | Not stated |
| EndoVive Safety PEG Kit Percutaneous Endoscopic Gastrostomy Kit | — | 8 | Not stated |
| EndoVive Button Right Angle Feeding Set Low Profile Button Continuous Feeding Set | — | 5 | Not stated |
| EndoVive Button Bolus Feeding Set Low Profile Button Bolus Feeding Set | — | 5 | Not stated |
| EndoVive Jejunal Feeding Tube 3-Port Through-the-PEG J-Tube Kit | — | 4 | Not stated |
| EndoVive Y-Port Feeding Adapter Initial Gastrostomy Tube Y-Port Adapter | — | 4 | Not stated |
| EndoVive C-Clamp Initial Gastrostomy Tube C-Clamp | — | 1 | Not stated |
| EndoVive Round Bolster Initial Gastrostomy Tube External Bolster | — | 1 | Not stated |
Guidewires
Used in: Uterine Artery Embolization (UAE), Peripheral Balloon Angioplasty, Stroke Thrombectomy, Internal Iliac Artery Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Amplatz Super Stiff Guidewire | — | 19 | Not stated |
| ChoICE Guidewire with ICE™ Hydrophilic Coating | — | 16 | Not stated |
| Platinum Plus PTCA Guidewire | — | 16 | Not stated |
| FATHOM -16 Steerable Guidewire | — | 9 | Not stated |
| PT² Guidewire | — | 8 | Not stated |
| ChoICE Magnet Guidewire with ICE™ Hydrophilic Coating | — | 8 | Not stated |
| PT Graphix Guidewire with ICE™ Hydrophilic Coating | — | 8 | Not stated |
| ChoICE PT Guidewire with ICE™ Hydrophilic Coating | — | 8 | Not stated |
| V-14 Control Wire Guidewire with ICE™ Hydrophilic Coating | — | 7 | Not stated |
| V-18 Control Wire Guidewire with ICE™ Hydrophilic Coating | — | 7 | Not stated |
| PT Graphix Magnet Guidewire with ICE™ Hydrophilic Coating | — | 6 | Not stated |
| ACUITY Whisper View Guide Wire with Hydrophilic Coating | — | 6 | Not stated |
| Transend Guidewire with ICE™ Hydrophilic Coating | — | 6 | Not stated |
| Kinetix PTCA Guidewire | — | 4 | Not stated |
| Transend EX Guidewire with ICE™ Hydrophilic Coating | — | 4 | Not stated |
| Samurai Guidewire | — | 4 | Not stated |
| Marvel Guidewire | — | 4 | Not stated |
| SAVION FLX Guidewire with ICE™ Hydrophilic coating | Outer Diameter: 0.37 mm; Outer Diameter: 0.01 in; Length: 185–300 cm | 4 | Not stated |
| FATHOM -14 Steerable Guidewire | — | 4 | Not stated |
| Mailman Guidewire with ICE™ Hydrophilic Coating | — | 4 | Not stated |
| Luge Guidewire with ICE™ Hydrophilic Coating | — | 4 | Not stated |
| SAVION DLVR Guidewire with ICE™ Hydrophilic coating | Outer Diameter: 0.37 mm; Outer Diameter: 0.01 in; Length: 182–300 cm | 4 | Not stated |
| Kinetix Plus PTCA Guidewire | — | 4 | Not stated |
| ChoICE PT Magnet Guidewire with ICE™ Hydrophilic coating | — | 4 | Not stated |
| Journey Guidewire | — | 4 | Not stated |
| FINISHING WIRE SUPPORTRAK Finishing Wire | — | 3 | Not stated |
| Back-Up Meier Steerable Guidewire | — | 3 | Not stated |
| Stingray Guidewire with Hydrophilic Coating | — | 3 | Not stated |
| JUDO 6 Guidewire | Outer Diameter: 0.01 in; Length: 190–300 cm | 2 | Not stated |
| Luge Magnet Guidewire with ICE™ Hydrophilic Coating | — | 2 | Not stated |
| JUDO 3 Guidewire | Length: 190–300 cm; Outer Diameter: 0.01 in | 2 | Not stated |
| Fighter Guidewire | — | 2 | Not stated |
| Mailman Magnet Guidewire with ICE™ Hydrophilic Coating | — | 2 | Not stated |
| Transend 300 Guidewire with ICE™ Hydrophilic Coating | — | 2 | Not stated |
| Hornet 14 Guidewire | — | 2 | Not stated |
| JUDO 1 Guidewire | Outer Diameter: 0.01 in; Length: 190–300 cm | 2 | Not stated |
| Magic Torque Glidex™ Coated Hydrophilic Guidewire | — | 2 | Not stated |
| Hornet Guidewire | — | 2 | Not stated |
| The Magnet Exchange Device | — | 2 | Not stated |
| Samurai RC Guidewire | — | 2 | Not stated |
| Hornet 10 Guidewire | — | 2 | Not stated |
| ACUITY Mailman Venous Guide Wire | — | 1 | Not stated |
| ACUITY Strait-Trak Venous Guide Wire | — | 1 | Not stated |
| Magic Torque DLVR Glidex™ Coated Hydrophilic Guidewire | Length: 315 cm; Outer Diameter: 0.91 mm; Outer Diameter: 0.04 in | 1 | Not stated |
| Comet II Pressure Guidewire | Outer Diameter: 0.36 mm; Length: 185 cm; Outer Diameter: 0.01 in | 1 | Not stated |
IVC Filters
Used in: IVC Filter Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Greenfield Vena Cava Filter | — | 4 | MR Conditional |
| Entry Kit For Use with Greenfield® Titanium Vena Cava Filter | — | 1 | Not stated |
Mechanical Thrombectomy Devices
Used in: DVT Mechanical Thrombectomy, Pulmonary Embolism Thrombectomy, Dialysis Graft and Fistula Thrombectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| SmartClaw Thrombectomy Catheter | Outer Diameter: 20–32 mm | 2 | Not stated |
| ZelanteDVT ClotHunter Helical Rotation Device | — | 1 | Not stated |
Microcatheters
Used in: Uterine Artery Embolization (UAE), Prostate Artery Embolization (PAE), Genicular Artery Embolization (GAE), Ovarian Vein Embolization, Varicocele Embolization, Transarterial Chemoembolization (TACE)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Direxion Torqueable Microcatheter | — | 16 | Not stated |
| TruSelect Microcatheter | Catheter Inner Diameter: 0.53–0.64 mm; Length: 105–155 cm; Catheter Length: 105–175 cm | 16 | Not stated |
| Direxion HI-FLO Torqueable Microcatheter | — | 12 | Not stated |
| Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter | Catheter Inner Diameter: 0.02 in; Guidewire Length: 200 cm; Catheter Working Length: 155 cm | 10 | Not stated |
| Renegade HI-FLO Microcatheter | — | 9 | Not stated |
| Direxion HI-FLO Fathom-16 System Pre-Loaded Torqueable Microcatheter | Guidewire Length: 200 cm; Catheter Working Length: 155 cm; Catheter Inner Diameter: 0.03 in | 8 | Not stated |
| Renegade HI-FLO FATHOM Kit Co-Packaged Microcatheter Kit | — | 8 | Not stated |
| Renegade HI-FLO FATHOM System Pre-Loaded Microcatheter System | — | 8 | Not stated |
| Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter | — | 7 | Not stated |
| Renegade HI-FLO Kit Microcatheter Kit | — | 6 | Not stated |
| Direxion HI-FLO Transend-18 System Pre-Loaded Torqueable Microcatheter | — | 4 | Not stated |
| Neuro Renegade Hi-Flo Microcatheter | — | 4 | Not stated |
| Renegade Fiber Braided Microcatheter | — | 3 | Not stated |
| Renegade - 18 Fiber Braided Microcatheter | — | 2 | Not stated |
| MAMBA Flex Microcatheter | — | 2 | Not stated |
| MAMBA Microcatheter | — | 1 | Not stated |
Nephrostomy and Nephroureteral Catheters
Used in: Nephrostomy Tube Placement, Nephroureteral Stent (PCNU) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Flexima Nephrostomy Catheter System | — | 21 | Not stated |
| NA Percutaneous Access Needle | — | 12 | Not stated |
| Amplatz Type Renal Sheath | — | 10 | Not stated |
| Percuflex Urinary Diversion Stent Urinary Diversion Stent | — | 9 | Not stated |
| VTC Nephrostomy Catheter System Kit | — | 8 | Not stated |
| Expel Drainage Catheter with Twist-Loc Hub Nephrostomy Drainage Catheter | — | 7 | MR Conditional |
| Percuflex Locking Loop Nephrostomy Catheter | — | 7 | MR Safe |
| Percuflex Urinary Diversion Stent Set Urinary Diversion Stent Set | — | 6 | Not stated |
| NaviGuide Percutaneous Access Needle | — | 5 | Not stated |
| Re-Entry Malecot Nephrostomy Catheter Set | — | 4 | Not stated |
| NephroMax High Pressure Nephrostomy Balloon Catheter | — | 4 | Not stated |
| NephroMax Kit High Pressure Nephrostomy Balloon Catheter Kit | — | 4 | Not stated |
| TLA Introducer Needle and Sheath Introducer Needle Set | — | 1 | Not stated |
| Clear Renal Sheath | — | 1 | Not stated |
Peripheral Artery Stents and Covered Stents
Used in: Peripheral Artery Stenting, Fistulogram with Angioplasty, Aneurysm and Pseudoaneurysm Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Epic Vascular Self-Expanding Stent System | — | 94 | MR Conditional |
| Innova Vascular Self-Expanding Stent System | — | 72 | MR Conditional |
| WALLSTENT RP Endoprosthesis Self-Expanding Stent | — | 40 | MR Conditional |
| Express LD Iliac / Biliary Premounted Stent System | — | 36 | MR Conditional |
| ELUVIA Drug-Eluting Vascular Stent System | Length: 75–130 cm; Length: 40–120 mm; Outer Diameter: 6–7 mm | 24 | MR Conditional |
Pulmonary Embolism Devices
Used in: Pulmonary Embolism Thrombectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| EKOS | — | 5 | Not stated |
Thrombolysis Infusion Catheters
Used in: DVT Mechanical Thrombectomy, Pulmonary Embolism Thrombectomy, Catheter-Directed Thrombolysis
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| EkoSonic The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic Core. The device delivers physician-specified fluids and ultrasound… | Length: 106–135 cm | 11 | Not stated |
| EKOS The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter and Ultrasonic Core to the Control Unit. | — | 7 | Not stated |
TIPS Stent Grafts and Access Sets
Used in: TIPS (Transjugular Intrahepatic Portosystemic Shunt)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| WALLSTENT Endoprosthesis Self-Expanding Stent | — | 3 | MR Conditional |
| WALLSTENT RP Endoprosthesis Self-Expanding Stent | — | 3 | MR Conditional |
Venous Stents
Used in: DVT Mechanical Thrombectomy, Venous Stenting (Iliac and Central Veins)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| VENOUS WALLSTENT Self-Expanding Stent | Catheter Length: 75–135 cm; Stent Diameter: 10–20 mm; Stent Length: 20–94 mm | 25 | MR Conditional |
Y-90 Radioembolization Microspheres
Used in: Y-90 Radioembolization (SIRT)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| TheraSphere YTTRIUM-90 GLASS MICROSPHERES | — | 35 | MR Safe |
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FDA clearances and approvals
- therasphere PMA P200029, 2021
- wallstent venous endoprosthesis with unistep plus delivery system PMA P980033, 2013
Product lines, models and sizes are compiled from the FDA Global Unique Device Identification Database (GUDID) and FDA clearance records. Descriptions marked "Provided by the manufacturer" come from the company and are reviewed before publishing.