Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42— 510(k) K213303
Substantially EquivalentInfraredx, Inc.
FDA 510(k) clearance K213303 for Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42, Substantially Equivalent on 2021-12-07. Applicant: Infraredx, Inc.. Device class: 2.
Clearance details
- Applicant
- Infraredx, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code IYO
view allMore clearances from Infraredx, Inc.
view all- K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i) +2 more
- K183599 — Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
- K163345 — TVC Imaging System, TVC Catheter
- K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
- K133897 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.