BARDEX LUBRI-SIL FOLEY CATHETER

BARDEX LUBRI-SIL FOLEY CATHETER is an FDA 510(k)-cleared medical device (K984084) manufactured by Bard Medical Div.. 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 31, 1999. Regulation: 8.