ENROUTE Transcarotid Neuroprotection System

ENROUTE Transcarotid Neuroprotection System is an FDA 510(k)-cleared medical device (K143072) manufactured by Silk Road Medical, 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 February 8, 2015. Regulation: 8.