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Cardio Flow Inc.,

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest Approval2025-04-25
TypeNumberDevice NameCodeDate
510(k) K250723 FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) MCW 2025-04-25 View
510(k) K242947 FreedomFlow™ Orbital Circumferential Atherectomy System MCW 2024-11-05 View
510(k) K233483 FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) MCW 2024-02-15 View
510(k) K231538 FreedomFlow Orbital Circumferential Atherectomy System MCW 2023-09-27 View
510(k) K213834 Cardio Flow Peripheral Guide Wire DQX 2022-03-18 View