Cardio Flow Inc., - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Cardio Flow Inc., has 5 FDA 510(k) cleared medical devices. Based in Mahtomedi, US.
Latest FDA clearance: Apr 2025. Active since 2022. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Cardio Flow Inc., Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Medical Devices Pathway, LLC and Quality & Regulatory Associates, LLC.
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