510(k) K172527

Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe by Cook Incorporated — Product Code LJE

K172527 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe". The FDA issued a decision of Substantially Equivalent on October 19, 2017. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Cook Incorporated has at least 10 other 510(k) clearances on record.