EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION

EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION is an FDA 510(k)-cleared medical device (K081467) manufactured by Ekos Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2008. Regulation: 8.