510(k) K031097

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB by Sophysa SA — Product Code JXG

K031097 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB". The FDA issued a decision of Substantially Equivalent on February 26, 2004. 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.