Aventus Thrombectomy System (IM-2100)— 510(k) K250668

Substantially Equivalent

Inquis Medical

FDA 510(k) clearance K250668 for Aventus Thrombectomy System (IM-2100), Substantially Equivalent on 2025-03-25. Applicant: Inquis Medical.

Clearance details

Applicant: Inquis Medical
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2025-03-05
Decision date: 2025-03-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.