Clearance Summary
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit received FDA 510(k) clearance under submission number K172455, sponsored by Volcano Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-10-25.
- Submission: K172455
- Applicant / Sponsor: Volcano Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2017-10-25
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.