DeviceClearance

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter— 510(k) K183599

Substantially Equivalent

Infraredx, Inc.

FDA 510(k) clearance K183599 for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter, Substantially Equivalent on 2019-04-12. 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
Burlington, MA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.