FDA Registration
Active
🇩🇰 Denmark
Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach
Reg #: 3002808486
·
FEI: 3002808486
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WILLIAM COOK EUROPE APS
- Registration Number
- 3002808486
- FEI Number
- 3002808486
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SANDET 6
- City
- BJAEVERSKOV Sjalland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K233680
Owner / Operator
- Firm Name
- WILLIAM COOK EUROPE APS
- Operator Number
- 9053266
- Address
- SANDET 6, DK-4632, --
- City
- BJAEVERSKOV
- State
- DK-NOTA
- Postal Code
- --
- Country
- DK
US Agent
- Business Name
- Cook Medical Holdings
- Contact Name
- Matt Graf
- Address
- 750 Daniels Way
- City
- BLOOMINGTON
- State
- IN
- ZIP
- 47404
- Country
- US
- [email protected]
- Phone
- 812 3392235
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Intravascular, Cardiovascular | DTK | Class 2 | Cardiovascular | No | 2024-07-03 |
Proprietary Names
Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach
Celect Platinum® Vena Cava Filter Set for Femoral Vein Approach
Celect Platinum® Vena Cava Filter Set for Jugular Vein Approach
Gunther Tulip® Vena Cava Filter Set for Jugular Vein Approach
Gunther Tulip® Vena Cava Filter Set for Femoral Vein Approach
Gunther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device