510(k) K241576
K241576 is an FDA 510(k) premarket notification submitted by Infraredx, Inc. for the device "Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )". The FDA issued a decision of Substantially Equivalent on February 26, 2025. The device falls under product code OGZ (Catheter, Intravascular, Plaque Morphology Evaluation), a Class II device regulated under 21 CFR 870.1200. Infraredx, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2025
- Date Received
- June 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Plaque Morphology Evaluation
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.