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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 22 of 22

Device	Model / Reference	Registries	Class	Status
Chocolate®	CB1812060120OTW	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-12-20-120	FDA UDI	Class II	Active
Nitrex™	N251801	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-20-120	FDA UDI	Class II	Unknown
Amplatz Goose Neck™	GN3000	FDA UDI	Class II	Active
Protégé™ GPS™	SERB65-09-40-120	FDA UDI	Class II	Active
Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model	K100063	FDA 510(k)	Class II	Active
Modification To: Nanocross 0.14 Otw Pta Dilatation Catheter, Models Ab14w020210090, Ab14w020210150	K090849	FDA 510(k)	Class II	Active
Modification To Nitrex Nitinol Guidewire	K040345	FDA 510(k)	Class II	Active
Spiderfx Embolic Protection Device	K063204	FDA 510(k)	Class II	Active
Primus Gps Biliary Stent System	K061566	FDA 510(k)	Class II	Active
Paramount Mini Gps Biliary Stent System	K040653	FDA 510(k)	Class II	Active
Protege Gps Self-Expanding Nitinol Stent	K050725	FDA 510(k)	Class II	Active
Paramount Mini Stent And Delivery System Biliary Indication	K032206	FDA 510(k)	Class II	Active
Powercross .018 Otw Pta Dilation Catheter	K093286	FDA 510(k)	Class II	Active
Spiderx Embolic Protection Device	K053195	FDA 510(k)	Class II	Active
Evercross .035 Otw Pta Dilatation Catheter	K082579	FDA 510(k)	Class II	Active
Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter	K130911	FDA 510(k)	Class II	Active
Turbohawk Peropheral Plaque Excision System	K103618	FDA 510(k)	Class II	Active
Trailblazer Support Catheter	K092299	FDA 510(k)	Class II	Active
Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter	K123544	FDA 510(k)	Class II	Active
X-Sizer Catheter System	K021096	FDA 510(k)	Class II	Active
Nanocross Eite 0.014 Over-The-Wire Pta Balloon Dilatation Catheter	K141118	FDA 510(k)	Class II	Active
Nitrex Nitinol Guidewire	K024021	FDA 510(k)	Class II	Active
Hyperglide Occlusion Balloon System	K090728	FDA 510(k)	Class II	Active
Protege Gps Self-Expanding Nitinol Stent And Delivery System	K032580	FDA 510(k)	Class II	Active
Spiderfx Embolic Protection Device	K111010	FDA 510(k)	Class II	Active
Protege Gps Self-Expanding Nitinol Stent And Delivery System	K033314	FDA 510(k)	Class II	Active
Nanocross Elite .14 Over-The-Wire Pta, Balloon Dilation Catheter	K132777	FDA 510(k)	Class II	Active
Turbohawk Peripheral Plaque Excision System	K093301	FDA 510(k)	Class II	Active
Evercross 0.035 Otw Pta Dilation Catheter	K103322	FDA 510(k)	Class II	Active
Nitrex Nitinol Guidewire	K031864	FDA 510(k)	Class II	Active
Marksman Catheter, *refers To Different Catheter Working Lenghts, Distal Single Coiled Lengths And Distal Shaft Lengths	K111490	FDA 510(k)	Class II	Active
Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow Hpc Flow Directed Micro Catheter, Reba	K093750	FDA 510(k)	Class II	Active
Primus Stent And Delivery System	K043243	FDA 510(k)	Class II	Active
Modification To Protege Gps Self-Expanding Nitinol Stent	K042204	FDA 510(k)	Class II	Active
Evercross 0.035 Otw Pta Dilatation Catheter	K110319	FDA 510(k)	Class II	Active
Protege Everflex Self-Expanding Biliary Stent System	K060057	FDA 510(k)	Class II	Active
Spiderx Embolic Protection Device	K052659	FDA 510(k)	Class II	Active
Spiderfx Embolic Protection Device	K063785	FDA 510(k)	Class II	Active
Protege Rx Gps Self-Expanding Nitrinol Stent	K051379	FDA 510(k)	Class II	Active
Modification To Paramount Mini Stent And Delivery System	K033134	FDA 510(k)	Class II	Active
Nanocorss .014 Otw Pta Dilatation Catheter	K082854	FDA 510(k)	Class II	Active
Turbohawk Peripheral Plaque Excision System	K111723	FDA 510(k)	Class II	Active
Spiderx Embolic Protection Device	K062201	FDA 510(k)	Class II	Active
5mm Protege Everflex Self Expanding Biliary Stent System, Model Prp35-05	K072301	FDA 510(k)	Class II	Active

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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.