510(k) K123298 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Mar 15, 2013 |
| Received | Oct 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2014 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS. Terminated |
DWF | None listed |
| Apr 16, 2014 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII0 Terminated |
DWF | None listed |
| Nov 1, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only,
Product Usage:
Aortic perfusion cannulae are intended for perfusion of the ascend Terminated |
DWF | None listed |
| Apr 14, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Duraflo coated Femoral Cannula.
Product Usage:
The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.