Clearance Summary
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System received FDA 510(k) clearance under submission number K152361, sponsored by Liebel-Flarsheim Company, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-01-14.
- Submission: K152361
- Applicant / Sponsor: Liebel-Flarsheim Company, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2016-01-14
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.