FDA Registration
Active
🇧🇪 Belgium
Stylet Models 4060, 4062, 4064. 4090, 4091, 4078
Reg #: 3012552532
·
FEI: 3012552532
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- St. Jude Medical Coordination Center BVBA European Distribution Center
- Registration Number
- 3012552532
- FEI Number
- 3012552532
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BruCargo 831
- City
- BruCargo Vlaams Brabant
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K090163
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 |
|---|---|---|---|---|---|
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2013-02-25 |
Proprietary Names
Stylet Models 4060, 4062, 4064. 4090, 4091, 4078
Establishment Types
Export Device to the United States But Perform No Other Operation on Device