510(k) K162016 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity NT Oxygenator with Cortiva BioActive Surface
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Sep 21, 2016 |
| Received | Jul 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162016
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.