Clearance Summary
Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter received FDA 510(k) clearance under submission number K183599, sponsored by Infraredx, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-04-12.
- Submission: K183599
- Applicant / Sponsor: Infraredx, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2019-04-12
Classification & Regulation
This clearance is catalogued under FDA product code OGZ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.