510(k) K151313— ZelanteDVT Thrombectomy Set

Substantially Equivalent

Boston Scientific Corporation

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2015-05-18
Decision date: 2015-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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.