ClearLumen II Thrombectomy System— 510(k) K161786

Unknown

Walk Vascular, LLC

FDA 510(k) clearance K161786 for ClearLumen II Thrombectomy System, Unknown on 2016-10-18. Applicant: Walk Vascular, LLC.

Clearance details

Applicant: Walk Vascular, LLC
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2016-06-29
Decision date: 2016-10-18
Decision: Unknown
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

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.