FDA Registration
Active
🇨🇷 Costa Rica
Supreme EP Catheter
Reg #: 3008452825
·
FEI: 3008452825
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Abbott Medical Costa Rica Ltda.
- Registration Number
- 3008452825
- FEI Number
- 3008452825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol
- City
- El Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K894500
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, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2007-12-11 |
Proprietary Names
Supreme EP Catheter
Response EP Catheter
Establishment Types
Manufacture Medical Device