510(k) K172071 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Mar 29, 2018 |
| Received | Jul 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172071
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.