510(k) K141869

QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT by Hemedex Incorporated — Product Code GWM

K141869 is an FDA 510(k) premarket notification submitted by Hemedex Incorporated for the device "QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT". The FDA issued a decision of Substantially Equivalent on October 10, 2014. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Hemedex Incorporated has at least 3 other 510(k) clearances on record.