510(k) K961734 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jul 7, 1997 |
| Received | May 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961734
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.