Cardio Flow Inc.,
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories2
Latest FDA decision2025-04-25
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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 |
No matching devices.