510(k) K140774 ยท DTZ Oxygenator, Cardiopulmonary Bypass
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Jun 2, 2014 |
| Received | Mar 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140774
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.