HAEMATURIA CATHETERS

HAEMATURIA CATHETERS is an FDA 510(k)-cleared medical device (K841511) manufactured by Warne Surgical Products, 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 11, 1984. Regulation: 8.