510(k) K080774 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Apr 17, 2008 |
| Received | Mar 19, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080774
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.