HydroCoil Embolic System (HES)

HydroCoil Embolic System (HES) is an FDA 510(k)-cleared medical device (K161367) manufactured by MicroVention, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2016. Regulation: 8.