K241553 is an FDA 510(k) clearance for the Auryon Atherectomy Catheter 1.7mm. 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 27, 2024, 27 days after receiving the submission on May 31, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4875.
| 510(k) Number | K241553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2024 |
| Decision Date | June 27, 2024 |
| Days to Decision | 27 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 |