510(k) K160223

VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter by Cook Incorporated — Product Code NHC

K160223 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code NHC (Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)), a Class II device regulated under 21 CFR 882.4100. Cook Incorporated has at least 10 other 510(k) clearances on record.