ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device— 510(k) K202218

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K202218 for ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device, Substantially Equivalent on 2020-10-02. Applicant: Boston Scientific Corporation.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2020-08-06
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, 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.