Octane Mechanical Thrombectomy System

Octane Mechanical Thrombectomy System is an FDA 510(k)-cleared medical device (K182232) manufactured by Vascular Solutions, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2018. Regulation: 8.