DUAL-LUMEN CATHETER

DUAL-LUMEN CATHETER is an FDA 510(k)-cleared medical device (K024165) manufactured by Bistech, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2003. Regulation: 8.