Clearance Summary
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip received FDA 510(k) clearance under submission number K160583, sponsored by Volcano Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-10-26.
- Submission: K160583
- Applicant / Sponsor: Volcano Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2016-10-26
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.