FDA 510(k) Applications Submitted by Michael J. Kallok

FDA 510(k) Number	Submission Date	Device Name	Applicant
K250723	03/10/2025	FreedomFlowÖ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)	Cardio Flow Inc.
K242947	09/25/2024	FreedomFlowÖ Orbital Circumferential Atherectomy System	Cardio Flow, Inc.
K233483	10/27/2023	FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)	Cardio Flow Inc.
K071350	05/14/2007	DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM	CARDIOVASCULAR SYSTEMS, INC.
K231538	05/30/2023	FreedomFlow Orbital Circumferential Atherectomy System	Cardio Flow, Inc.
K213834	12/09/2021	Cardio Flow Peripheral Guide Wire	Cardio Flow, Inc.