FDA Registration
Active
🇺🇸 United States
Steerable Guide Catheter
Reg #: 3005070406
·
FEI: 3005070406
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Vascular
- Registration Number
- 3005070406
- FEI Number
- 3005070406
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3885 Bohannon Drive
- City
- Menlo Park
- State
- CA
- ZIP
- 94025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190167
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 |
|---|---|---|---|---|---|
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2019-07-17 |
Proprietary Names
Steerable Guide Catheter
Establishment Types
Manufacture Medical Device