K250723 is an FDA 510(k) clearance for the FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration). This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Cardio Flow Inc., (Blaine, US). The FDA issued a Cleared decision on April 25, 2025, 46 days after receiving the submission on March 10, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K250723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2025 |
| Decision Date | April 25, 2025 |
| Days to Decision | 46 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MCW - Catheter, Peripheral, Atherectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4875 |