510(k) K140208 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
| Applicant | Edwards Lifesciences, LLC, Draper UT, US |
| Decision | Substantially Equivalent, Mar 5, 2014 |
| Received | Jan 28, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2025 | Edwards Lifesciences, LLC Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII016A
Software Version: N/A
Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or e Open, Classified |
DQR | None listed |
| Jul 10, 2025 | Edwards Lifesciences, LLC Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII016AS
Software Version: N/A
Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or Open, Classified |
DQR | None listed |
| Jul 10, 2025 | Edwards Lifesciences, LLC Brand Name: FEM-FLEX II
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII018A
Software Version: N/A
Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or e Open, Classified |
DQR | None listed |
| Jul 10, 2025 | Edwards Lifesciences, LLC Brand Name: FEM-FLEXII
Product Name: Femoral Arterial Cannula
Model/Catalog Number: FEMII018AS
Software Version: N/A
Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or Open, Classified |
DQR | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. Terminated |
DWF | None listed |
| Mar 7, 2018 | SPS Sterilization, Inc Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. Terminated |
DWF | None listed |
| Apr 2, 2015 | Edwards Lifesciences, LLC Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEM Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.