510(k) K200260

Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System by Boston Scientific Corporation — Product Code FAD

K200260 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System". The FDA issued a decision of Substantially Equivalent (kit) on April 26, 2021. 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.