Submission Details
| 510(k) Number | K230709 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Auryon Atherectomy System
Jun 2023
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K230709 is an FDA 510(k) clearance for the Auryon Atherectomy System, 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 review panel. Regulated under 21 CFR 870.4875.
Device Classification
| Product Code | MCW — Catheter, Peripheral, Atherectomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4875 |
Manufacturer
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