FDA Registration
Active
🇺🇸 United States
Hi-Torque Winn
Reg #: 3005737652
·
FEI: 3005737652
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ABBOTT VASCULAR
- Registration Number
- 3005737652
- FEI Number
- 3005737652
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building PR-17, Road #2, km 58.0, Cruce Davila
- City
- BARCELONETA
- State
- PR
- ZIP
- 00617
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101648
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2010-08-11 |
Proprietary Names
Hi-Torque Winn
Establishment Types
Manufacture Medical Device