EkoSonic Endovascular System with Control Unit 4.0

EkoSonic Endovascular System with Control Unit 4.0 is an FDA 510(k)-cleared medical device (K162771) manufactured by Btg International, 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 23, 2017. Regulation: 8.