MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
FDA 510(k) clearance K041979 · decided 2004-09-02
Clearance details
- K-number
- K041979
- Device name
- MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
- Applicant
- Quest Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-23
- Decision date
- 2004-09-02
- Days to decision
- 41 days
- Clearance type
- Special
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Allen, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software cont recall (Z-1924-2011) | Quest Medical, Inc | 2011-04-08 |