510(k) K120072 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, May 8, 2012 |
| Received | Jan 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120072
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized. Terminated |
DWF | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.3MM) X 40CM (16"), resterilized. Terminated |
DWF | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.3MM) X 37CM (14.5"), resterilized. Terminated |
DWF | None listed |
| Dec 9, 2015 | Edwards Lifesciences, LLC Thin-Flex Venous Cannula, Model Number:TF292902A Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.