Clearance Summary
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); received FDA 510(k) clearance under submission number K233895, sponsored by Edwards Lifesciences. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-02-05.
- Submission: K233895
- Applicant / Sponsor: Edwards Lifesciences
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2024-02-05
Classification & Regulation
This clearance is catalogued under FDA product code DWF and 21 CFR 870.4210, within the Cardiovascular review panel as a Class II device.