510(k) K191444 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 27, 2019 |
| Received | May 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191444
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.