FDA 510(k) Applications Submitted by Stephen Sum
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K241576 |
06/03/2024 |
Makoto Intravascular Imaging SystemÖ (VC-MC10 / TVC-MC10i); DualproÖ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) |
Infraredx, Inc. |
| 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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