510(k) K172626 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Oct 25, 2017 |
| Received | Sep 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172626
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.