510(k) K041979 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Sep 2, 2004 |
| Received | Jul 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.