510(k) K200499
K200499 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "QuickDraw Venous Cannula". The FDA issued a decision of Substantially Equivalent on Mar 29, 2020. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 29, 2020
- Date Received
- Feb 28, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4210
- Review Panel
- CV
- Submission Type
- 510(k)