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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 16 of 22

Device	Model / Reference	Registries	Class	Status
NanoCross™ Elite	AB14W050080090	FDA UDI	Class II	Active
NanoCross™	AB14W035040150	FDA UDI	Class II	Active
Nitrex™	N143001	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-80-80	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W060080090	FDA UDI	Class II	Active
EverFlex	PRB35-06-120-120	FDA UDI	Class III	Unknown
EverCross™	AB35W07120135	FDA UDI	Class II	Active
Chocolate®	CB1413535040OTW	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020100150	FDA UDI	Class II	Active
EverCross™	AB35W09020135	FDA UDI	Class II	Active
EverCross™	AB35W06080135	FDA UDI	Class II	Active
NanoCross™	AB14W035210150	FDA UDI	Class II	Active
EverCross™	AB35W08020080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020120150	FDA UDI	Class II	Active
Protégé EverFlex™	PRB35-05-100-080	FDA UDI	Class III	Active
EverCross™	AB35W05150080	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-14-40-80	FDA UDI	Class II	Active
NanoCross™	AB14W040040150	FDA UDI	Class II	Active
EverFlex	PRB35-08-030-120	FDA UDI	Class II	Unknown
Protégé™ GPS™	SERB65-09-30-80	FDA UDI	Class III	Active
EverFlex	PRB35-06-040-080	FDA UDI	Class III	Unknown
EverFlex	PRB35-08-100-120	FDA UDI	Class II	Unknown
EverFlex	PRB35-07-030-080	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W020060150	FDA UDI	Class II	Active
Nitrex™	N183002	FDA UDI	Class II	Active
Protégé EverFlex™	PRB35-05-060-080	FDA UDI	Class III	Active
EverCross™	AB35W04080080	FDA UDI	Class II	Active
EverCross™	AB35W04200135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040080150	FDA UDI	Class II	Active
NanoCross™	AB14W020120090	FDA UDI	Class II	Active
EverCross™	AB35W03060135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025020090	FDA UDI	Class II	Active
EverCross™	AB35W12060135	FDA UDI	Class II	Active
EverFlex	PRB35-06-060-080	FDA UDI	Class II	Active
EverCross™	AB35W04020080	FDA UDI	Class II	Active
Nitrex™	N181804	FDA UDI	Class II	Active
EverCross™	AB35W06150080	FDA UDI	Class II	Active
EverCross™	AB35W07060080	FDA UDI	Class II	Active
EverCross™	AB35W07100135	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-030-120	FDA UDI	Class III	Active
NanoCross™	AB14W030080150	FDA UDI	Class II	Active
EverCross™	AB35W03020135	FDA UDI	Class II	Active
EverCross™	AB35W06100135	FDA UDI	Class II	Active
EverCross™	AB35W07060135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050060150	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-14-20-80	FDA UDI	Class II	Active
EverCross™	AB35W04040080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W030040150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W015020090	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-06-020-080	FDA UDI	Class III	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.