510(k) K201068 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 21, 2020 |
| Received | Apr 22, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201068
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.