Submission Details
| 510(k) Number | K221077 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 12, 2022 |
| Decision Date | June 09, 2022 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Auryon Atherectomy System
Jun 2022
Decision
58d
Days
Class 2
Risk
About This 510(k) Submission
K221077 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, 2022, 58 days after receiving the submission on April 12, 2022. 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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