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Sign in to claim this brandEV3, INC
US
Last updated May 24, 2026
What EV3, INC makes
EV3, Inc. manufactures peripheral vascular devices, including basic angioplasty balloon catheters, bare-metal peripheral artery stents, and manual vascular guidewires. Their portfolio also covers single-use vascular guide-catheters, intravascular extraction catheters with snare functionality, bare-metal biliary stents, and embolic protection filtering guidewires. Additional products include peripheral vascular guidewire extensions and specialized guidewires designed for protection during interventions.
The company’s devices are regulated under FDA Class II and Class III classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. EV3, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- medtronic.com
- —
- —
- [email protected]
- Phone
- +1(800)633-8766
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117446916
Catalogue (1096)
Page 18 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nitrex™ | N180801 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W050040150 | FDA UDI | Class II | Active |
| EverCross™ | AB35W03060080 | FDA UDI | Class II | Active |
| EverCross™ | AB35W03120135 | FDA UDI | Class II | Active |
| Protégé™ GPS™ | SERB65-09-40-120 | FDA UDI | Class III | Active |
| EverCross™ | AB35W03030080 | FDA UDI | Class II | Active |
| Nitrex™ | N351455 | FDA UDI | Class II | Active |
| EverCross™ | AB35W07020135 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W060100150 | FDA UDI | Class II | Active |
| Protégé™ GPS™ | SERB65-09-20-80 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W040100090 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W030210150 | FDA UDI | Class II | Active |
| EverCross™ | AB35W07150135 | FDA UDI | Class II | Active |
| Viance™ | VNC-FX-150 | FDA UDI | Class II | Active |
| EverCross™ | AB35W09030080 | FDA UDI | Class II | Active |
| EverCross™ | AB35W05040080 | FDA UDI | Class II | Active |
| EverFlex™ Protégé™ EverFlex™ | PRB35-08-200-120 | FDA UDI | Class III | Active |
| TrailBlazer™ | SC-014-135 | FDA UDI | Class II | Active |
| EverCross™ | AB35W09020135 | FDA UDI | Class II | Active |
| EverFlex | PRB35-06-040-120 | FDA UDI | Class III | Unknown |
| EverCross™ | AB35W08020080 | FDA UDI | Class II | Active |
| EverCross™ | AB35W03150135 | FDA UDI | Class II | Active |
| EverCross™ | AB35W05080135 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W035150150 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W050150150 | FDA UDI | Class II | Active |
| EverCross™ | AB35W08060080 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W030020150 | FDA UDI | Class II | Active |
| NanoCross™ | AB14W035020150 | FDA UDI | Class II | Active |
| NanoCross™ | AB14W025040090 | FDA UDI | Class II | Active |
| EverCross™ | AB35W07080135 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W035040090 | FDA UDI | Class II | Active |
| EverCross™ | AB35W04080135 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W060020090 | FDA UDI | Class II | Active |
| EverCross™ | AB35W05040040 | FDA UDI | Class II | Active |
| EverCross™ | AB35W06120040 | FDA UDI | Class II | Active |
| Protégé™ GPS™ | SERB65-09-40-80 | FDA UDI | Class III | Active |
| Protégé EverFlex™ | PRB35-05-080-120 | FDA UDI | Class III | Active |
| EverCross™ | AB35W07020040 | FDA UDI | Class II | Active |
| Nitrex™ | N351452 | FDA UDI | Class II | Active |
| EverCross™ | AB35W12040135 | FDA UDI | Class II | Active |
| EverCross™ | AB35W03080080 | FDA UDI | Class II | Active |
| Nitrex™ | N180601 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W025020150 | FDA UDI | Class II | Active |
| NanoCross™ | AB14W030120150 | FDA UDI | Class II | Active |
| EverCross™ | AB35W04200135 | FDA UDI | Class II | Active |
| EverCross™ | AB35W09080080 | FDA UDI | Class II | Active |
| EverCross™ | AB35W05200135 | FDA UDI | Class II | Active |
| EverFlex | PRB35-07-080-080 | FDA UDI | Class III | Unknown |
| EverCross™ | AB35W04060135 | FDA UDI | Class II | Active |
| NanoCross™ Elite | AB14W060040090 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
EV3, Inc. has one FDA recall record initiated on March 29, 2016, for the PowerCross 0.018" Over the Wire Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. The recall involves two lots and was conducted voluntarily by Medtronic, with the reason stated as mislabeling. The recall status is recorded as terminated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 29, 2016 | Z-1552-2016 | — | terminated | Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled. |