510(k) K213303

Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 by Infraredx, Inc. — Product Code IYO

K213303 is an FDA 510(k) premarket notification submitted by Infraredx, Inc. for the device "Makoto Intravascular Imaging System, TVC-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 December 7, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Infraredx, Inc. has at least 10 other 510(k) clearances on record.