ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT

ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT is an FDA 510(k)-cleared medical device (K895417) manufactured by Arrow Intl., 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 January 2, 1990. Regulation: 8.