510(k) K050875

U-BALLOON DILATION CATHETER by C.R. Bard, Inc. — Product Code EZN

K050875 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "U-BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.