510(k) K213303 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
| Applicant | Infraredx, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 7, 2021 |
| Received | Oct 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213303
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.