HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX

HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX is an FDA 510(k)-cleared medical device (K041726) manufactured by Asahi Medical Co., Ltd.. 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 July 22, 2004. Regulation: 8.