510(k) K821538 ยท DTP Defoamer, Cardiopulmonary Bypass
CAPIOX CR-CARDIOTOMY RESERVOIR
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Aug 6, 1982 |
| Received | May 24, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821538
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.