ClearLumen II Thrombectomy System

ClearLumen II Thrombectomy System is an FDA 510(k)-cleared medical device (K161786) 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 October 17, 2016. Regulation: 8.