Clearance Summary
Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae received FDA 510(k) clearance under submission number K162215, 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 2017-06-16.
- Submission: K162215
- 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: 2017-06-16
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.