FDA Registration
Active
🇺🇸 United States
TwinFlo Catheter (Heparin Coated)
Reg #: 3005034471
·
FEI: 3005034471
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THERMOPEUTIX INC.
- Registration Number
- 3005034471
- FEI Number
- 3005034471
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11760 Justen Circle, Unit A
- City
- Maple Grove
- State
- MN
- ZIP
- 55369
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093847
Owner / Operator
- Firm Name
- THERMOPEUTIX INC.
- Operator Number
- 9070236
- Address
- 11760 Justen Circle, Unit A
- City
- Maple Grove
- State
- MN
- Postal Code
- 55369
- Country
- US
- Correspondent
- Glen - Lieber
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2012-01-26 |
Proprietary Names
TwinFlo Catheter (Heparin Coated)
Establishment Types
Manufacture Medical Device