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SILK ROAD MEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 14755 27th Avenue North, Plymouth, MN, 55447
Website: silkroadmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-855-410-8227
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3022627847
DUNS Number: 022516829

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
ENROUTE Transcarotid Stent	SR-0620-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0740-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0830-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Neuroprotection System	FG12531	FDA UDI	Class II	Active
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0720-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-5525-BC	FDA UDI	Class II	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-4535-BC	FDA UDI	Class II	Active
ENROUTE .014" Guidewire	11686-01	FDA UDI	Class II	Active
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0920-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-1040-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0630-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-1030-CS	FDA UDI	Class III	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-6035-BC	FDA UDI	Class II	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-5035-BC	FDA UDI	Class II	Active
ENROUTE Transcarotid Stent	SR-0530-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Neuroprotection System	SR-200-NPS	FDA UDI	Class II	Unknown
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-4035-BC	FDA UDI	Class II	Active
ENROUTE Transcarotid Neuroprotection System	SR-201-NPS	FDA UDI	Class II	Unknown
ENROUTE Transcarotid Stent	SR-0540-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0940-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0640-CS	FDA UDI	Class III	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-6025-BC	FDA UDI	Class II	Active
ENROUTE Transcarotid Stent	SR-0730-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0520-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Neuroprotection System	FG12522	FDA UDI	Class II	Active
ENROUTE Transcarotid Stent	SR-0840-CS	FDA UDI	Class III	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-4525-BC	FDA UDI	Class II	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-5025-BC	FDA UDI	Class II	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	SR-5535-BC	FDA UDI	Class II	Active
ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter	SR-4025-BC	FDA UDI	Class II	Active
ENROUTE Transcarotid Stent	SR-1020-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0930-CS	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	FG11815	FDA UDI	Class III	Active
ENROUTE Transcarotid Stent	SR-0820-CS	FDA UDI	Class III	Active
ENROUTE .014" Guidewire	11686-01	FDA UDI	Class II	Active
Silk Road Access Catheter	K130649	FDA 510(k)	Class II	Active
ENROUTE Transcarotid Neuroprotection System	K153485	FDA 510(k)	Class II	Active
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	K221414	FDA 510(k)	Class II	Active
ENROUTE Transcarotid Neuroprotection System	K143072	FDA 510(k)	Class II	Active
ENROUTE® Transcarotid Neuroprotection System	K230402	FDA 510(k)	Class II	Active
Silk Road Acccess Catheter	K143459	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
Jan 13, 2021	Z-1146-2021	—	terminated	Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.