Clearance Summary
NC TREK RX CORONARY DILATATION CATHETER received FDA 510(k) clearance under submission number K110134, sponsored by Abbott Vascular-Cardiac Therapies. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-02-11.
- Submission: K110134
- Applicant / Sponsor: Abbott Vascular-Cardiac Therapies
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5100
- Decision date: 2011-02-11
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.