FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
FDA 510(k) clearance K123298 · decided 2013-03-15
Clearance details
- K-number
- K123298
- Device name
- FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-10-23
- Decision date
- 2013-03-15
- Days to decision
- 143 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, recall (Z-1466-2014) | Edwards Lifesciences, LLC | 2014-04-16 |
| Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arter recall (Z-1467-2014) | Edwards Lifesciences, LLC | 2014-04-16 |
| Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX recall (Z-0135-2014) | Edwards Lifesciences, LLC | 2013-11-01 |
| Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are inten recall (Z-1111-2013) | Edwards Lifesciences, LLC | 2013-04-14 |