510(k) K920342

BARD STONE REMOVAL BALLOON CATHETER by C.R. Bard, Inc. — Product Code GCA

K920342 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD STONE REMOVAL BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on August 26, 1992. The device falls under product code GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection), a Class II device regulated under 21 CFR 876.5010. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.