DeviceClearance

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER— 510(k) K141682

Substantially Equivalent

Infraredx, Inc.

FDA 510(k) clearance K141682 for TVC IMAGING SYSTEM, TVC INSIGHT CATHETER, Substantially Equivalent on 2014-11-24. 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.