510(k) K233483

FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) by Cardio Flow Inc., — Product Code MCW

K233483 is an FDA 510(k) premarket notification submitted by Cardio Flow Inc., for the device "FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)". The FDA issued a decision of Substantially Equivalent on February 15, 2024. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Cardio Flow Inc., has at least 4 other 510(k) clearances on record.