510(k) K191077 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 Cortive BioActive Surface, Medtronic External Drive Motor
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 27, 2019 |
| Received | Apr 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191077
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.