510(k) K070839 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Apr 24, 2007 |
| Received | Mar 27, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070839
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.