FDA Registration
Active
🇺🇸 United States
Cormatrix ECM for Carotid Repair
Reg #: 1835959
·
FEI: 3002340648
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COOK BIOTECH, INC.
- Registration Number
- 1835959
- FEI Number
- 3002340648
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1425 INNOVATION PLACE
- City
- West Lafayette
- State
- IN
- ZIP
- 47906
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111187
Owner / Operator
- Firm Name
- COOK BIOTECH, INC.
- Operator Number
- 9031415
- Address
- 1425 INNOVATION PLACE, --
- City
- West Lafayette
- State
- IN
- Postal Code
- 47906
- Country
- US
- Correspondent
- Monica A Bravo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2014-08-27 |
Proprietary Names
Cormatrix ECM for Carotid Repair
VasCure for Carotid Repair
ECM for Carotid Repair
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)