FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) is an FDA 510(k)-cleared medical device (K233483) 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 February 14, 2024. Regulation: 8.