510(k) K123187 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Oct 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123187
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.