ARGYLE HEMATURIA BALLOON CATHETER

ARGYLE HEMATURIA BALLOON CATHETER is an FDA 510(k)-cleared medical device (K802875) manufactured by Sherwood Medical Co.. 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 December 15, 1980. Regulation: 8.