510(k) K141227

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX by Sophysa SA — Product Code JXG

K141227 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX". The FDA issued a decision of Substantially Equivalent on April 2, 2015. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Sophysa SA has at least 10 other 510(k) clearances on record.