510(k) K013526 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
CAPIOX RX HARDSHELL RESERVOIR
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Nov 15, 2001 |
| Received | Oct 23, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013526
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.