Clearance Summary
HORIZON XVU (FFR) received FDA 510(k) clearance under submission number K123792, sponsored by Mennen 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 2013-08-30.
- Submission: K123792
- Applicant / Sponsor: Mennen Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2013-08-30
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.