510(k) K113411 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Jun 11, 2012 |
| Received | Nov 18, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2014 | Edwards Lifesciences, LLC Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012
Atrial Vent Catheters are intended for venting the left Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.