510(k) K171994

Silicone Peripherally Inserted Central Venous Catheter Set/Tray by Cook Incorporated — Product Code LJS

K171994 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Silicone Peripherally Inserted Central Venous Catheter Set/Tray". The FDA issued a decision of Substantially Equivalent on Feb 22, 2018. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Cook Incorporated has 174 other 510(k) clearances on record.