Ev3, Inc
15 product lines across 5 device categories: Angioplasty balloons, Biliary drains, Embolic protection, Guidewires, Peripheral stents.
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 PTA AB35W06120040 EVERCROSS 035 V05 | Catheter Gauge: 5–7 Fr; Length: 20–200 mm; Outer Diameter: 3–12 mm | 140 | Not stated |
| NanoCross Elite PTA AB14W035060090 NANOCROSS 014 V05 | Length: 20–210 mm; Outer Diameter: 1.5–6 mm; Catheter Gauge: 4–6 Fr | 116 | Not stated |
| NanoCross PTA AB14W020150150 NANOCROSS 014 V03 | Length: 20–210 mm; Outer Diameter: 1.5–4 mm | 50 | Not stated |
| Chocolate PTA CB1812060040 CHOCOLATE 018 V03 | Balloon Diameter: 2.5–6 mm; Balloon Length: 40–120 mm; Length: 120–150 cm | 18 | Not stated |
Biliary Drainage Catheters
Used in: Percutaneous Biliary Drainage (PTBD)
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| Protégé GPS STENT SERB65-14-80-120 PROTEGE GPS V05 | Length: 20–80 mm; Catheter Gauge: 6 Fr | 10 | MR Conditional |
| Protégé EverFlex STENT PRB35-05-080-080 PROTEGE EF V08 | Catheter Gauge: 6 Fr; Length: 20–80 mm | 9 | MR Conditional |
Embolic Protection Devices
Used in: Carotid Artery Stenting
| Product | Sizes (FDA GUDID) | Models | MRI |
|---|---|---|---|
| SpiderFX EP SPD2-US-060-190 SPIDER FX V04 | Length: 190–320 cm; Outer Diameter: 3–7 mm | 10 | 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 GW N354001 NITREX V04 | Guidewire Diameter: 0.36–0.89 mm; Guidewire Length: 60–400 cm | 31 | Not stated |
| Wholey GW WWSS35300 WHOLEY WIRE STND STR 300CM | Guidewire Length: 145–300 cm; Guidewire Diameter: 0.09 cm | 13 | Not stated |
| Babywire GW BW1200 BABY WIRE V04 | Guidewire Length: 18–50 cm; Guidewire Diameter: 0.31 mm | 2 | Not stated |
| Kendall GW WWTD35001 WHOLEY WIRE TORQUE DEVICE | — | 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 |
|---|---|---|---|
| EverFlex Protégé EverFlex STENT PRB35-08-120-120 PROTEGE EF V07 | Catheter Gauge: 6 Fr; Length: 20–200 mm | 51 | MR Conditional |
| EverFlex STENT PRB35-07-030-080 PROTEGE EF V09 | Catheter Gauge: 6 Fr; Length: 20–150 mm | 40 | Not stated |
| Protégé GPS STENT SERB65-10-40-120 PROTEGE GPS V06 | Length: 20–80 mm; Catheter Gauge: 6 Fr | 30 | MR Conditional |
| Protégé EverFlex STENT PRB35-05-080-080 PROTEGE EF V08 | Catheter Gauge: 6 Fr; Length: 20–120 mm | 14 | MR Conditional |
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FDA clearances and approvals
- nanocorss 014 otw pta dilatation catheter 510K K082854, 2008
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.