BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS

BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS is an FDA 510(k)-cleared medical device (K040504) manufactured by C.R. Bard, Inc.. 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 May 13, 2004. Regulation: 8.