TVC Imaging System, TVC Catheter

TVC Imaging System, TVC Catheter is an FDA 510(k)-cleared medical device (K163345) manufactured by Infraredx, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2017. Regulation: 8.