ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is an FDA 510(k)-cleared medical device (K173063) 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 October 22, 2017. Regulation: 8.