510(k) K153295 ยท DTZ Oxygenator, Cardiopulmonary Bypass
TandemLung Oxygenator
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, Feb 26, 2016 |
| Received | Nov 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153295
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.