HEMODIALYSIS BLOOD LINES

HEMODIALYSIS BLOOD LINES is an FDA 510(k)-cleared medical device (K900306) manufactured by Gainor Medical Europe, 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 April 19, 1990. Regulation: 8.