Infraredx, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest FDA decision2025-02-26
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K241576 | Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | OGZ | 2025-02-26 | View |
| 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 | IYO | 2021-12-07 | View |
| 510(k) | K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | OGZ | 2019-04-12 | View |
| 510(k) | K163345 | TVC Imaging System, TVC Catheter | OGZ | 2017-06-21 | View |
No matching devices.