Clearance Summary
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box received FDA 510(k) clearance under submission number K152582, sponsored by Volcano Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2015-12-03.
- Submission: K152582
- Applicant / Sponsor: Volcano Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 2015-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.