Clearance Summary
CorSens received FDA 510(k) clearance under submission number K160656, sponsored by Corsens Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-11-21.
- Submission: K160656
- Applicant / Sponsor: Corsens Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2320
- Decision date: 2016-11-21
Classification & Regulation
This clearance is catalogued under FDA product code DXR and 21 CFR 870.2320, within the Cardiovascular review panel as a Class II device.