K230709 is an FDA 510(k) clearance for the Auryon Atherectomy System. This device is classified as a Catheter, Peripheral, Atherectomy (Class II - Special Controls, product code MCW).
Submitted by Eximo Medical, Ltd. (Rehovot, IL). The FDA issued a Cleared decision on June 9, 2023, 87 days after receiving the submission on March 14, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K230709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2023 |
| Decision Date | June 09, 2023 |
| Days to Decision | 87 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 |