Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )— 510(k) K241576
Substantially EquivalentInfraredx, Inc.
FDA 510(k) clearance K241576 for Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ), Substantially Equivalent on 2025-02-26. Applicant: Infraredx, Inc..
Clearance details
- Applicant
- Infraredx, Inc.
- Product code
- Code OGZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.