Cardio Flow Inc., - FDA 510(k) Cleared Devices
Recent clearances: FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration), FreedomFlow™ Orbital Circumferential Atherectomy System, FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardio Flow Inc., Cardiovascular ✕
5 devices
Cleared
Apr 25, 2025
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere...
Cardiovascular
46d
Cleared
Nov 05, 2024
FreedomFlow™ Orbital Circumferential Atherectomy System
Cardiovascular
41d
Cleared
Feb 15, 2024
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere...
Cardiovascular
111d
Cleared
Sep 27, 2023
FreedomFlow Orbital Circumferential Atherectomy System
Cardiovascular
120d
Cleared
Mar 18, 2022
Cardio Flow Peripheral Guide Wire
Cardiovascular
99d