510(k) K120543 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
TANDEMHEART FEMORAL ARTERIAL CANNULA SET
| Applicant | Cardiacassist, Inc., Pittsburgh PA, US |
| Decision | Substantially Equivalent, May 30, 2012 |
| Received | Feb 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120543
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.