Clearance Summary
HORIZON ANGIO CATHLAB received FDA 510(k) clearance under submission number K043564, sponsored by Mennen Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-01-27.
- Submission: K043564
- Applicant / Sponsor: Mennen Medical , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1425
- Decision date: 2005-01-27
Classification & Regulation
This clearance is catalogued under FDA product code DQK and 21 CFR 870.1425, within the Cardiovascular review panel as a Class II device.