510(k) K082321 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
| Applicant | Terumo Cardiovascular Systems Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Feb 13, 2009 |
| Received | Aug 13, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082321
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.