ClearLumen II Peripheral Thrombectomy System

ClearLumen II Peripheral Thrombectomy System is an FDA 510(k)-cleared medical device (K172000) 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 23, 2017. Regulation: 8.