510(k) K983101

BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 by C.R. Bard, Inc. — Product Code MJC

K983101 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24". The FDA issued a decision of Substantially Equivalent on November 3, 1998. 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.