OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD is an FDA 510(k)-cleared medical device (K213593) 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 January 13, 2022. Regulation: 8.