Aventus Thrombectomy System— 510(k) K253925

Substantially Equivalent

Inquis Medical

FDA 510(k) clearance K253925 for Aventus Thrombectomy System, Substantially Equivalent on 2026-01-15. Applicant: Inquis Medical.

Clearance details

Applicant: Inquis Medical
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2025-12-08
Decision date: 2026-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, 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.