FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
FDA 510(k) clearance K140208 · decided 2014-03-05
Clearance details
- K-number
- K140208
- Device name
- FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-01-28
- Decision date
- 2014-03-05
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII recall (Z-2082-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII recall (Z-2083-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII recall (Z-2084-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII0 recall (Z-2085-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx recall (Z-1371-2015) | Edwards Lifesciences, LLC | 2015-04-02 |