K241576
- 510(k) number
- K241576
- Device name
- 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. MA · US
- Product code
- OGZ — Catheter, Intravascular, Plaque Morphology Evaluatio
- Decision date
- 2025-02-26
- Date received
- 2024-06-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241576.pdf
Official FDA record: K241576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.