Covidien LP
42 product lines across 12 device categories: Ablation systems, Angioplasty balloons, Atherectomy, Biliary drains, Biopsy needles, Carotid stents.
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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 |
|---|---|---|---|
| Emprint Long Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone | Length: 15–190 cm | 12 | Not stated |
| Emprint SX Field Generator | Length: 15–30 cm | 11 | Not stated |
| Evident MWA Surgical Antenna | Length: 12–22 cm | 6 | Not stated |
| Cool-Tip Ablation Remote Temperature Probe | Length: 20 cm | 3 | Not stated |
| Emprint HP Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking. | — | 3 | Not stated |
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 |
|---|---|---|---|
| EverCross .035 | Catheter Gauge: 5–7 Fr; Outer Diameter: 3–12 mm; Length: 20–200 mm | 140 | Not stated |
| PowerCross .018 | Outer Diameter: 0.5–6 mm; Length: 20–200 mm; Catheter Gauge: 4–6 Fr | 84 | Not stated |
| RapidCross PTA A14BX030040170 RAPIDCROSS V03 | Length: 20–210 mm; Outer Diameter: 2–4 mm; Catheter Gauge: 4 Fr | 80 | Not stated |
| Fortrex PTA A35HPV05020040 FORTREX V02 | Outer Diameter: 4–12 mm; Length: 40–135 cm; Catheter Gauge: 6–7 Fr | 75 | Not stated |
| NanoCross PTA AB14W030150090 NANOCROSS 014 V03 | Length: 20–210 mm; Outer Diameter: 2–4 mm | 12 | Not stated |
Atherectomy Devices
Used in: Peripheral Atherectomy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| SilverHawk Cutter Driver for Plaque Excision Systems | Catheter Gauge: 6–8 Fr; Outer Diameter: 1.9–2.7 mm; Length: 2.2–104 cm | 9 | Not stated |
| SilverHawkTM ATHERECTOMY P4055 SILVERHAWK ATK V03 | — | 8 | Not stated |
| TurboHawk ATHERECTOMY THS-SS-CL TURBOHAWK BTK V03 | Length: 3.9–145 cm; Outer Diameter: 2.2–2.7 mm; Catheter Gauge: 6–8 Fr | 7 | Not stated |
| HawkOne ATHERECTOMY H1-14550 CUTTER DRIVER UNI | Catheter Gauge: 6–7 Fr; Outer Diameter: 2.2–2.6 mm; Length: 104–145 cm | 5 | Not stated |
| TurboHawkTM ATHERECTOMY TH-LS-M TURBOHAWK ATK V06 | — | 1 | Not stated |
| HawkOneTM ATHERECTOMY H1-14550 CUTTERDRIVER V02 | — | 1 | Not stated |
| N/A ATHERECTOMY FG02550 CUTTERDRIVER V04 | — | 1 | Not stated |
Biliary Drainage Catheters
Used in: Percutaneous Biliary Drainage (PTBD)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Protege GPS Self-Expanding Biliary Stent System | Length: 20–80 mm; Outer Diameter: 6–14 mm; Catheter Gauge: 6 Fr | 70 | Not stated |
| Visi-Pro Balloon-Expandable Biliary Stent System | Outer Diameter: 2.2–10 mm; Length: 12–57 mm; Catheter Gauge: 6–7 Fr | 51 | Not stated |
| Paramount Mini GPS Balloon-Expandable Biliary Stent System | Length: 14–21 mm; Outer Diameter: 5–7 mm; Catheter Gauge: 5–6 Fr | 18 | Not stated |
| Protege EverFlex Self-Expanding Biliary Stent System | Length: 20–120 mm; Outer Diameter: 5 mm; Catheter Gauge: 6 Fr | 14 | Not stated |
| IntraStent LD DoubleStrut Large Diameter Biliary Stent | Length: 16–76 mm | 5 | Not stated |
| IntraStent LD Max Large Diameter Peripheral Stent | Length: 16–36 mm; Outer Diameter: 12 mm | 3 | Not stated |
| IntraStent LD Mega Large Diameter Biliary Stent | Length: 16–36 mm | 3 | Not stated |
| Protege RX Self-Expanding Biliary Stent System | Outer Diameter: 8 mm; Length: 135 cm; Catheter Gauge: 6 Fr | 1 | Not stated |
Biopsy Needles and Systems
Used in: Image-Guided Needle Biopsy
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| SharkCore Fine Needle Biopsy Needle | Needle Gauge: 22–25 G | 6 | Not stated |
Carotid Stents
Used in: Carotid Artery Stenting
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Protege RX Carotid Stent System | Length: 20–60 mm; Catheter Gauge: 6 Fr; Outer Diameter: 7 mm | 20 | MR Conditional |
| Protege RX Tapered Carotid Stent System | Length: 30–40 mm; Catheter Gauge: 6 Fr | 4 | MR Conditional |
Embolic Protection Devices
Used in: Carotid Artery Stenting
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| SpiderFX Embolic Protection Device | Outer Diameter: 3–7 mm; Length: 190–320 cm; Outer Diameter: 0.01 in | 10 | Not stated |
Flow Diverters
Used in: Flow Diverter Placement for Brain Aneurysm
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Pipeline Embolization Device | Length: 10 mm; Outer Diameter: 2.5 mm | 1 | MR Conditional |
Gastrostomy and GJ Tubes
Used in: Gastrostomy (G-Tube) Placement, Gastrojejunostomy (GJ-Tube) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Kangaroo Nasogastric Feeding Tube,7 g Weighted Dobbhoff Tip, Rigid Port, Stylet | — | 5 | Not stated |
| GastriSail Gastric Positioning System | Outer Diameter: 36 mm; Catheter Gauge: 40 Fr | 2 | Not stated |
Guidewires
Used in: Uterine Artery Embolization (UAE), Peripheral Balloon Angioplasty, Stroke Thrombectomy, Internal Iliac Artery Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| NITREX Guidewire | Length: 60–400 cm; Outer Diameter: 0.01–0.04 in; Outer Diameter: 0.09 cm | 31 | Not stated |
| AqWire Hydrophilic Guidewire | Outer Diameter: 0.02–0.04 in; Length: 150–260 cm | 18 | Not stated |
| Wholey GW WWFS35175 WHOLEY WIRE V03 | Guidewire Diameter: 0.09 cm; Guidewire Length: 145–300 cm; Length: 145–300 cm | 13 | Not stated |
| ClosureFast Guidewire,J Tip, PTFE, Fixed Core,0.025"" (0.64 mm) x 260 cm | Length: 45–260 cm; Outer Diameter: 0.02–0.04 in; Width: 0.02 in | 5 | Not stated |
| Enteer Guidewire;Standard | Outer Diameter: 0.01 in; Length: 300 cm | 3 | Not stated |
| Babywire Double Ended Nitinol Guidewire | Length: 18–50 cm; Outer Diameter: 0.01 in | 2 | Not stated |
| Kendall GW WWTD35001 WHOLEY WIRE V03 | — | 1 | Not stated |
Implanted Ports (Port-a-Cath)
Used in: Port-a-Cath (Implanted Port) Placement
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Chemosite Venous Access System | Outer Diameter: 0.04–2.8 mm; Length: 19–50 mm; Total Volume: 12 mL | 28 | MR Conditional |
Peripheral Artery Stents and Covered Stents
Used in: Peripheral Artery Stenting, Fistulogram with Angioplasty, Aneurysm and Pseudoaneurysm Embolization
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| EverFlex Self-Expanding Peripheral Stent System | Length: 20–200 mm; Catheter Gauge: 5–6 Fr; Outer Diameter: 2–8 mm | 118 | Not stated |
| Visi-Pro PXB35-10-17-135 STENT VISI PRO 035 V01 | Length: 12–57 mm; Outer Diameter: 5–10 mm; Catheter Gauge: 6–7 Fr | 51 | MR Conditional |
Sales representatives
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FDA clearances and approvals
- emprint ablation system with thermosphere technology 510K K200796, 2020
- silverhawk peripheral plaque excision system turbohawk peripheral plaque excision system 510K K170191, 2017
- emprint ablation system 510K K163105, 2016
- hawkone directional atherectomy system 510K K161361, 2016
- hawkone directional atherectomy system 510K K141801, 2014
- turbohawk peripheral plaque excision system 510K K111723, 2011
- turbohawk peropheral plaque excision system 510K K103618, 2011
- turbohawk peripheral plaque excision system 510K K093301, 2009
- nanocorss 014 otw pta dilatation catheter 510K K082854, 2008
- silverhawk peripheral plaque excision system 510K K061188, 2006
- vivatip microwave ablation probe 510K K032702, 2003
- modified hydrophilic coated guidewire 510K K000011, 2000
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.