510(k) K151389 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Oct 20, 2015 |
| Received | May 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151389
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.