DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is an FDA 510(k)-cleared medical device (K101843) manufactured by AngioDynamics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 2010. Regulation: 8.