Submission Details
| 510(k) Number | K220116 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 14, 2022 |
| Decision Date | September 26, 2022 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Auryon Atherectomy Catheters
Sep 2022
Decision
255d
Days
Class 2
Risk
About This 510(k) Submission
K220116 is an FDA 510(k) clearance for the Auryon Atherectomy Catheters, 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 September 26, 2022, 255 days after receiving the submission on January 14, 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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