510(k) K172984 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Nov 20, 2017 |
| Received | Sep 27, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172984
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.