K213303 is an FDA 510(k) clearance for the Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Infraredx, Inc. (Bedford, US). The FDA issued a Cleared decision on December 7, 2021, 64 days after receiving the submission on October 4, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K213303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2021 |
| Decision Date | December 07, 2021 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |