510(k) K173414

Advance Biliary Balloon Catheter by Cook Incorporated — Product Code GCA

K173414 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Advance Biliary Balloon Catheter". The FDA issued a decision of Substantially Equivalent (kit) on June 22, 2018. 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. Cook Incorporated has at least 10 other 510(k) clearances on record.