Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating— 510(k) K241553

Substantially Equivalent

Eximo Medical, Ltd.

FDA 510(k) clearance K241553 for Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating, Substantially Equivalent on 2024-06-27. Applicant: Eximo Medical, Ltd..

Clearance details

Applicant: Eximo Medical, Ltd.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2024-05-31
Decision date: 2024-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.