Clearance Summary
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE received FDA 510(k) clearance under submission number K103101, 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 2011-02-10.
- Submission: K103101
- Applicant / Sponsor: Abbott Vascular-Cardiac Therapies
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2011-02-10
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.