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

Name: FDA 510(k) clearance K202218
Creator: U.S. Food and Drug Administration
Published: 2020-10-02

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. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code QEW
Device class: Class 2
Regulation: 21 CFR 870.5150
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 ↗

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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.