MYOCARDIAL PROTECTION SYSTEM
FDA 510(k) clearance K953838 · decided 1996-03-06
Clearance details
- K-number
- K953838
- Device name
- MYOCARDIAL PROTECTION SYSTEM
- Applicant
- Quest Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-16
- Decision date
- 1996-03-06
- Days to decision
- 203 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 recall (Z-0361-2016) | Quest Medical, Inc. | 2015-12-02 |
| 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 |
| Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes recall (Z-1037-03) | Quest Medical, Inc | 2003-07-22 |