Auryon Atherectomy System
Device Facts
| Record ID | K260244 |
|---|---|
| Device Name | Auryon Atherectomy System |
| Applicant | Eximo Medical |
| Product Code | MCW · Cardiovascular |
| Decision Date | Apr 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
