
Ekos Corp.
Free shipping on orders over $99 · 30-day returns
ENDOWAVE INFUSION SYSTEM is an FDA 510(k)-cleared medical device (K071933) 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 August 9, 2007. Regulation: 8.