OptiCross™ 18 Peripheral Imaging Catheter

OptiCross™ 18 Peripheral Imaging Catheter is an FDA 510(k)-cleared medical device (K222568) 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 September 22, 2022. Regulation: 8.