BARDEX LUBRI-SIL I.C. FOLEY CATHETER

BARDEX LUBRI-SIL I.C. FOLEY CATHETER is an FDA 510(k)-cleared medical device (K984136) 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 February 15, 1999. Regulation: 8.