Clearance Summary
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 received FDA 510(k) clearance under submission number K213303, sponsored by Infraredx, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-12-07.
- Submission: K213303
- Applicant / Sponsor: Infraredx, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2021-12-07
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.