510(k) K910318

BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER by C.R. Bard, Inc. — Product Code MJC

K910318 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on August 18, 1994. The device falls under product code MJC (Catheter, Urological (Antimicrobial) And Accessories), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.