510(k) K172929

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath by Boston Scientific Corporation — Product Code LJE

K172929 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath". The FDA issued a decision of Substantially Equivalent on January 10, 2018. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.