FDA 510(k) Applications Submitted by Stephen Sum

FDA 510(k) Number Submission Date Device Name Applicant
K213303 10/04/2021 Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 Infraredx, Inc.
K163345 11/29/2016 TVC Imaging System, TVC Catheter Infraredx, Inc.
K183599 12/26/2018 Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter Infraredx, Inc.


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