B-Laser Atherectomy System— 510(k) K181642

Substantially Equivalent

Eximo Medical, Ltd.

FDA 510(k) clearance K181642 for B-Laser Atherectomy System, Substantially Equivalent on 2018-10-05. Applicant: Eximo Medical, Ltd..

Clearance details

Applicant: Eximo Medical, Ltd.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2018-06-21
Decision date: 2018-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
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.