510(k) K111657 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Jun 23, 2011 |
| Received | Jun 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111657
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.