510(k) K153213 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Dec 3, 2015 |
| Received | Nov 5, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153213
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.