INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER

INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER is an FDA 510(k)-cleared medical device (K912600) manufactured by Intertherapy, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 1991. Regulation: 8.