FDA 510(k) Applications Submitted by Cardio Flow Inc.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K250723 | 03/10/2025 | FreedomFlowÖ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow Inc. |
| K233483 | 10/27/2023 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow Inc. |
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