Clearance Summary
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line received FDA 510(k) clearance under submission number K200612, sponsored by Sorin Group Italia S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-11-17.
- Submission: K200612
- Applicant / Sponsor: Sorin Group Italia S.R.L.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4210
- Decision date: 2020-11-17
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.