Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is an FDA 510(k)-cleared medical device (K181042) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 16, 2018. Regulation: 8.