FDA Registration
Active
🇺🇸 United States
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach
Reg #: 3005580113
·
FEI: 3005580113
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COOK MEDICAL LLC
- Registration Number
- 3005580113
- FEI Number
- 3005580113
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 400 DANIELS WAY
- City
- Bloomington
- State
- IN
- ZIP
- 47404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172557
Owner / Operator
- Firm Name
- COOK MEDICAL
- Operator Number
- 9090900
- Address
- 400 DANIELS WAY, --
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
- Correspondent
- Ed - Sutkowski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filter, Intravascular, Cardiovascular | DTK | Class 2 | Cardiovascular | No | 2019-07-25 |
Proprietary Names
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
Establishment Types
Complaint File Establishment per 21 CFR 820.198