510(k) K191446

Ureteral Stent Systems, Biliary Drainage Catheters by Boston Scientific Corporation — Product Code FAD

K191446 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Ureteral Stent Systems, Biliary Drainage Catheters". The FDA issued a decision of Substantially Equivalent (kit) on January 2, 2020. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.