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EV3, INC

Last updated May 24, 2026

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 7 of 22

Device	Model / Reference	Registries	Class	Status
Chocolate®	CB1415030080OTW	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W040210090	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W025080090	FDA UDI	Class II	Active
EverCross™	AB35W06100135	FDA UDI	Class II	Active
EverCross™	AB35W06020080	FDA UDI	Class II	Active
EverFlex	PRB35-07-040-080	FDA UDI	Class III	Unknown
NanoCross™ Elite	AB14W030080150	FDA UDI	Class II	Active
EverCross™	AB35W03120080	FDA UDI	Class II	Active
EverFlex	PRB35-06-020-120	FDA UDI	Class II	Unknown
NanoCross™ Elite	AB14W050120150	FDA UDI	Class II	Active
EverCross™	AB35W05080040	FDA UDI	Class II	Active
EverCross™	AB35W06020135	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-30-80	FDA UDI	Class III	Unknown
EverFlex™ Protégé™ EverFlex™	PRB35-08-080-120	FDA UDI	Class III	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-040-080	FDA UDI	Class III	Active
Protégé™ GPS™	SERB65-10-80-120	FDA UDI	Class III	Unknown
EverCross™	AB35W03100080	FDA UDI	Class II	Active
EverFlex	PRB35-08-100-080	FDA UDI	Class II	Unknown
TrailBlazer™	SC-014-135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W050040150	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020080090	FDA UDI	Class II	Active
EverCross™	AB35W08080135	FDA UDI	Class II	Active
EverCross™	AB35W09080135	FDA UDI	Class II	Active
EverCross™	AB35W08060040	FDA UDI	Class II	Active
EverCross™	AB35W06200080	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W060200150	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-60-80	FDA UDI	Class III	Active
EverCross™	AB35W09020135	FDA UDI	Class II	Active
TrailBlazer™	SC-018-090	FDA UDI	Class II	Active
EverCross™	AB35W07200080	FDA UDI	Class II	Active
EverFlex	PRB35-08-120-080	FDA UDI	Class II	Unknown
EverCross™	AB35W05120080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-08-040-120	FDA UDI	Class III	Active
NanoCross™ Elite	AB14W050020090	FDA UDI	Class II	Active
EverCross™	AB35W08020040	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-14-80-80	FDA UDI	Class II	Active
EverCross™	AB35W03040135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W020040150	FDA UDI	Class II	Active
EverCross™	AB35W07080080	FDA UDI	Class II	Active
EverCross™	AB35W12060080	FDA UDI	Class II	Active
Wholey™	WWSS35300	FDA UDI	Class II	Active
EverCross™	AB35W07120080	FDA UDI	Class II	Active
EverFlex™ Protégé™ EverFlex™	PRB35-07-030-080	FDA UDI	Class III	Active
EverCross™	AB35W06200135	FDA UDI	Class II	Active
NanoCross™ Elite	AB14W035080090	FDA UDI	Class II	Active
EverCross™	AB35W07120135	FDA UDI	Class II	Active
TrailBlazer™	SC-035-065	FDA UDI	Class II	Unknown
EverFlex™ Protégé™ EverFlex™	PRB35-08-040-080	FDA UDI	Class III	Active
Protégé™ GPS™	SERB65-10-80-80	FDA UDI	Class II	Active
EverCross™	AB35W10030080	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.

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.