CLEARLUMEN THROMBECTOMY SYSTEM

CLEARLUMEN THROMBECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K140296) manufactured by Walk Vascular, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2014. Regulation: 8.