Cardio Flow Inc.,

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)April 25, 2025
K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemNovember 5, 2024
K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)February 15, 2024
K231538FreedomFlow Orbital Circumferential Atherectomy SystemSeptember 27, 2023
K213834Cardio Flow Peripheral Guide WireMarch 18, 2022