EKOS PE Endovascular Device with Control System 4.0 (CS4.0)

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is an FDA 510(k)-cleared medical device (K200648) manufactured by Ekos Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 2020. Regulation: 8.