510(k) K162448

White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter by Cook Incorporated — Product Code DQO

K162448 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter". The FDA issued a decision of Substantially Equivalent on May 26, 2017. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Cook Incorporated has 174 other 510(k) clearances on record.