510(k) K100631 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
AFFIITY CP CENTRIFUGAL BLOOD PUMP
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 22, 2010 |
| Received | Mar 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100631
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.