LATEX FOLEY CATHETER (HYDROMER COATED)

LATEX FOLEY CATHETER (HYDROMER COATED) is an FDA 510(k)-cleared medical device (K801415) manufactured by G.D. Searle and 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 August 19, 1980. Regulation: 8.