FDA Registration
Active
🇳🇱 Netherlands
GORE® Molding and Occlusion Balloon Catheter
Reg #: 3015138222
·
FEI: 3015138222
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gore European Warehouse Support
- Registration Number
- 3015138222
- FEI Number
- 3015138222
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Doctor Paul Janssenweg 150
- City
- Tilburg Noord-Brabant
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K172567
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
US Agent
- Business Name
- W. L. GORE & ASSOCIATES, INC.
- Contact Name
- Lisa Wells
- Address
- 1505 N Fourth St.
- City
- Flagstaff
- State
- AZ
- ZIP
- 86004
- Country
- US
- [email protected]
- Phone
- 928 8644219
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2018-02-08 |
Proprietary Names
GORE® Molding and Occlusion Balloon Catheter
Establishment Types
Manufacture Medical Device