510(k) K161504

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray by Cook Incorporated — Product Code MPB

K161504 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 6, 2017. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Cook Incorporated has at least 10 other 510(k) clearances on record.