FDA Registration
Active
🇺🇸 United States
GORE-TEX Vascular Graft
Reg #: 2017233
·
FEI: 2017233
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- W. L. GORE & ASSOCIATES, INC
- Registration Number
- 2017233
- FEI Number
- 2017233
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1505 NORTH FOURTH ST.
- City
- FLAGSTAFF
- State
- AZ
- ZIP
- 86004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K901641
Owner / Operator
- Firm Name
- W. L. GORE & ASSOCIATES, INC.
- Operator Number
- 9925013
- Address
- 1505 North Fourth Street
- City
- Flagstaff
- State
- AZ
- Postal Code
- 86004
- Country
- US
- Correspondent
- Lisa Wells
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | Class 2 | Cardiovascular | No | 2007-12-19 |
Proprietary Names
GORE-TEX Vascular Graft
Establishment Types
Manufacture Medical Device