FreedomFlow™ Orbital Circumferential Atherectomy System

FreedomFlow™ Orbital Circumferential Atherectomy System is an FDA 510(k)-cleared medical device (K242947) manufactured by Cardio Flow 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 November 4, 2024. Regulation: 8.