QuickClear Mechanical Thrombectomy System— 510(k) K193197

Substantially Equivalent

Volcano Atheromed, Inc.

FDA 510(k) clearance K193197 for QuickClear Mechanical Thrombectomy System, Substantially Equivalent on 2020-04-20. Applicant: Volcano Atheromed, Inc..

Clearance details

Applicant: Volcano Atheromed, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2019-11-20
Decision date: 2020-04-20
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.