FDA Registration
Active
🇺🇸 United States
ENROUTE Transcarotid Stent System
Reg #: 3022627847
·
FEI: 3022627847
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Silk Road Medical
- Registration Number
- 3022627847
- FEI Number
- 3022627847
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14755 27th Avenue North
- City
- Plymouth
- State
- MN
- ZIP
- 55447
- Country
- US
Regulatory Submissions
- PMA Number
- P140026
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
- Correspondent
- Adrienne Bishop
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Carotid | NIM | Class 3 | Unknown | No | 2024-10-14 |
Proprietary Names
ENROUTE Transcarotid Stent System
Establishment Types
Manufacture Medical Device