AMECATH DUAL LUMEN HEMODIALYSIS CATHETER

AMECATH DUAL LUMEN HEMODIALYSIS CATHETER is an FDA 510(k)-cleared medical device (K123943) manufactured by Ameco Medical Industries. 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 April 1, 2013. Regulation: 8.