Identity
- Trade Name
- ENROUTE Transcarotid Neuroprotection System FDA UDI
- Generic Name
- Embolic protection filtering guidewire FDA UDI
- Device Name
- Angled-Tip Arterial Sheath Configuration FDA UDI
- Model / Reference
- FG12522 FDA UDI
- Description
- Angled-Tip Arterial Sheath Configuration FDA UDI
Identifiers
- Catalog Number
- SR-200-NPS FDA UDI
- Primary DI / UDI-DI
- 00811311020829 FDA UDI
- FDA Product Code
- NTE FDA UDI
- GMDN Term
- Embolic protection filtering guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Embolic protection filtering guidewire
ENROUTE Transcarotid Neuroprotection System by Silk Road Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Embolic protection filtering guidewire.
- ANGIOGUARD — Cordis Corp. · Class II
- EMBOSHIELD NAV6 — Abbott Vascular · Class II
- EMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLC · Class II
- ProCatid System kit Finished Good — Gardia Medical · Class II
- SpiderFX™ — EV3, INC · Class II
- EMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLC · Class II
- FilterWire EZ™ — Boston Scientific · Class II
- SpiderFX™ — EV3, INC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Silk Road Medical, Inc.
Sources (1)
- FDA UDI 9130f4e8-0fc0-4c99-90e5-c60f7dceeb8d 35 fields · synced May 30, 2026