FDA Registration
Active
🇺🇸 United States
CATHTEK LLC
Reg #: 3027553380
·
FEI: 3027553380
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CATHTEK LLC
- Registration Number
- 3027553380
- FEI Number
- 3027553380
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4790 Walkertown Plaza Blvd
- City
- Walkertown
- State
- NC
- ZIP
- 27051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210570
Owner / Operator
- Firm Name
- Cathtek LLC
- Operator Number
- 10042470
- Address
- 3825 Reidsville Road
- City
- Winston Salem
- State
- NC
- Postal Code
- 27101
- Country
- US
- Correspondent
- Jessica Hughes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2021-12-22 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)