ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING

ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING is an FDA 510(k)-cleared medical device (K913636) manufactured by Cordis Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 11, 1991. Regulation: 8.