QuickDraw Venous Cannula
FDA 510(k) clearance K200499 · decided 2020-03-29
Clearance details
- K-number
- K200499
- Device name
- QuickDraw Venous Cannula
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-02-28
- Decision date
- 2020-03-29
- Days to decision
- 30 days
- Clearance type
- Special
- 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
No recalls on record reference this clearance.