510(k) K191609

Tria Soft Ureteral Stent by Boston Scientific Corporation — Product Code FAD

K191609 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Tria Soft Ureteral Stent". The FDA issued a decision of Substantially Equivalent on August 16, 2019. 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.