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EV3, INC

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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-8766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117446916

Catalogue (1096)

Page 11 of 22

Device	Model / Reference	Registries	Class	Status
EverCross™	AB35W03040080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050080150	FDA UDI	Class II	Active
EverCross™	AB35W03120135	FDA UDI	Class II	Active
EverCross™	AB35W09060135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030100090	FDA UDI	Class II	Active
EverCross™	AB35W08060080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-120-080	FDA UDI	Class III	Active
EverCross™	AB35W06040040	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-80-120	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W030120090	FDA UDI	Class II	Active
Nitrex™	N353001	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040150090	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-10-20-120	FDA UDI	Class III	Active
EverCross™	AB35W06040080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060120090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025020150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040120150	FDA UDI	Class II	Active
EverCross™	AB35W06150135	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-020-120	FDA UDI	Class III	Active
EverCross™	AB35W06040135	FDA UDI	Class II	Active
SpiderFX™	SPD2-US-050-190	FDA UDI	Class II	Unknown
EverCross™	AB35W05030080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W035150150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040210150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040120150	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-30-120	FDA UDI	Class II	Unknown
Protégé™ GPS™	SERB65-09-80-80	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W015020150	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-10-80-120	FDA UDI	Class III	Active
Nitrex™	N352601	FDA UDI	Class II	Active
NanoCross™	AB14W025040150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050020090	FDA UDI	Class II	Active
EverCross™	AB35W05100080	FDA UDI	Class II	Active
NanoCross™	AB14W040210150	FDA UDI	Class II	Active
EverCross™	AB35W09060080	FDA UDI	Class II	Active
EverCross™	AB35W05060040	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-14-80-120	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-020-080	FDA UDI	Class III	Active
Protégé EverFlex™	PRB35-05-040-080	FDA UDI	Class III	Active
EverFlex	PRB35-08-060-080	FDA UDI	Class II	Unknown
EverFlex™ Protégé™ EverFlex™	PRB35-06-080-120	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W025080150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W035210090	FDA UDI	Class II	Active
EverCross™	AB35W07020135	FDA UDI	Class II	Active
EverCross™	AB35W06120040	FDA UDI	Class II	Active
EverFlex	PRB35-06-120-120	FDA UDI	Class II	Unknown
NanoCross™ Elite	AB14W030060090	FDA UDI	Class II	Active
EverCross™	AB35W06040040	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-40-120	FDA UDI	Class III	Unknown
EverCross™	AB35W12060080	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.