510(k) K113667 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Jan 12, 2012 |
| Received | Dec 13, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113667
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.