510(k) K002392

VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V by Integra Neurocare, LLC — Product Code GWM

K002392 is an FDA 510(k) premarket notification submitted by Integra Neurocare, LLC for the device "VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V". The FDA issued a decision of Substantially Equivalent on November 2, 2000. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Integra Neurocare, LLC has at least 10 other 510(k) clearances on record.