VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
FDA 510(k) clearance K120072 · decided 2012-05-08
Clearance details
- K-number
- K120072
- Device name
- VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-01-10
- Decision date
- 2012-05-08
- Days to decision
- 119 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 |
|---|---|---|
| Thin-Flex Venous Cannula, Model Number:TF292902A recall (Z-0398-2016) | Edwards Lifesciences, LLC | 2015-12-09 |