510(k) K964371

SHUNT TAP WITH ICP MONITORING ACCESS PORT by Integra Neurocare, LLC — Product Code JXG

K964371 is an FDA 510(k) premarket notification submitted by Integra Neurocare, LLC for the device "SHUNT TAP WITH ICP MONITORING ACCESS PORT". The FDA issued a decision of Substantially Equivalent on January 31, 1997. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Neurocare, LLC has at least 10 other 510(k) clearances on record.