510(k) K153143 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Capiox Advance Hardshell Reservoir
| Applicant | Terumo Cardiovascular Systems Corporation, Elkton MD, US |
| Decision | Substantially Equivalent, Dec 2, 2015 |
| Received | Oct 30, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153143
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.