ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter is an FDA 510(k)-cleared medical device (K193183) manufactured by Acist Medical Systems, 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 March 19, 2020. Regulation: 8.