FDA Registration
Active
🇺🇸 United States
Myocardial Protection System (MPS) 2
Reg #: 1649914
·
FEI: 3001665800
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUEST MEDICAL, INC.
- Registration Number
- 1649914
- FEI Number
- 3001665800
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Allentown Pkwy
- City
- ALLEN
- State
- TX
- ZIP
- 75002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041979
Owner / Operator
- Firm Name
- ATRION CORP.
- Operator Number
- 9914015
- Address
- ONE ALLENTOWN PKWY., --
- City
- Allen
- State
- TX
- Postal Code
- 75002
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | Class 2 | Cardiovascular | No | 2007-11-19 |
Proprietary Names
Myocardial Protection System (MPS) 2
Establishment Types
Manufacture Medical Device