510(k) K132712 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Nov 19, 2013 |
| Received | Aug 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132712
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.