ENROUTE® Transcarotid Neuroprotection System

ENROUTE® Transcarotid Neuroprotection System is an FDA 510(k)-cleared medical device (K230402) manufactured by Silk Road Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2023. Regulation: 8.