FEM-FLEX FEMORAL ACCESS CANNULATION SET
FDA 510(k) clearance K891576 · decided 1989-10-12
Clearance details
- K-number
- K891576
- Device name
- FEM-FLEX FEMORAL ACCESS CANNULATION SET
- Applicant
- Research Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-20
- Decision date
- 1989-10-12
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII0 recall (Z-1893-2008) | Edwards Lifesciences Research Medical, Inc. | 2008-09-11 |
| Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11. recall (Z-1894-2008) | Edwards Lifesciences Research Medical, Inc. | 2008-09-11 |