510(k) K071572 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
| Applicant | Terumo Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jul 23, 2007 |
| Received | Jun 8, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071572
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.