Auryon Atherectomy System— 510(k) K260244
Substantially EquivalentEximo Medical
FDA 510(k) clearance K260244 for Auryon Atherectomy System, Substantially Equivalent on 2026-04-10. Applicant: Eximo Medical. Device class: 2.
Summary
The Auryon Atherectomy System is filed under MCW, peripheral atherectomy catheters. The record doesn't describe how it works.
Class II, 21 CFR 870.4875. The Cardiovascular panel reviewed it as a Traditional 510(k).
Eximo Medical filed from Rehovot, Israel. Review took 73 days (January 27 to April 10, 2026).
Clearance details
- Applicant
- Eximo Medical
- Product code
- Product code MCW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rehovot, IL
Recent devices under product code MCW
view all- K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
- K250385 — Turbo-Elite Laser Atherectomy Catheter
- K242757 — Rotarex Atherectomy System
- K242947 — FreedomFlow Orbital Circumferential Atherectomy System
- K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating
Adverse events under product code MCW
product code MCW- Death
- 38
- Injury
- 1,386
- Malfunction
- 2,676
- Other
- 2
- Total
- 4,102
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.