Clearance Summary
Foresight Intracardiac Echocardiology (ICE) System received FDA 510(k) clearance under submission number K162789, sponsored by Conavi Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-03-28.
- Submission: K162789
- Applicant / Sponsor: Conavi Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2017-03-28
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.