Device Listing 1973671864
Listing Summary#
- Listing key
- 1973671864
- Premarket submission
- K241576
- Device
- Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
- Applicant
- Infraredx, Inc.
- Product code
- OGZ
- Decision date
- 2025-02-26