K233483 is an FDA 510(k) clearance for the FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 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 February 15, 2024, 111 days after receiving the submission on October 27, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K233483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2023 |
| Decision Date | February 15, 2024 |
| Days to Decision | 111 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 |