Clearance Summary
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER received FDA 510(k) clearance under submission number K103153, sponsored by Abbott Vascular-Cardiac Therapies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-12-30.
- Submission: K103153
- Applicant / Sponsor: Abbott Vascular-Cardiac Therapies
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5100
- Decision date: 2010-12-30
Classification & Regulation
This clearance is catalogued under FDA product code LOX and 21 CFR 870.5100, within the Cardiovascular review panel as a Class II device.