EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
FDA 510(k) clearance K033464 · decided 2004-06-22
Clearance details
- K-number
- K033464
- Device name
- EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-10-31
- Decision date
- 2004-06-22
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, 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 |