Submission Details
| 510(k) Number | K202835 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2020 |
| Decision Date | December 02, 2020 |
| Days to Decision | 68 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Auryon Atherectomy System
Dec 2020
Decision
68d
Days
Class 2
Risk
About This 510(k) Submission
K202835 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 December 2, 2020, 68 days after receiving the submission on September 25, 2020. 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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