510(k) K200438 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
MPS 3 Myocardial Protection System
| Applicant | Quest Medical, Inc., Allen TX, US |
| Decision | Substantially Equivalent, Jun 19, 2020 |
| Received | Feb 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200438
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.