TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER is an FDA 510(k)-cleared medical device (K133897) 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 April 22, 2014. Regulation: 8.