Octane Mechanical Thrombectomy System— 510(k) K182232

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K182232 for Octane Mechanical Thrombectomy System, Substantially Equivalent on 2018-09-11. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: 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

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.