510(k) K953838 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MYOCARDIAL PROTECTION SYSTEM
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Mar 6, 1996 |
| Received | Aug 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2015 | Quest Medical, Inc. Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volum Terminated |
DTR | None listed |
| Apr 8, 2011 | Quest Medical, Inc Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat Terminated |
DTR | None listed |
| Jul 22, 2003 | Quest Medical, Inc Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.