K182232

Substantially Equivalent

Octane Mechanical Thrombectomy System

Applicant: Vascular Solutions, Inc.
Product code: QEZ
Advisory panel: Cardiovascular
Date received: 2018-08-17
Decision date: 2018-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Maple Grove, MN, US

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.