510(k) K090342

POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 by Sophysa SA — Product Code JXG

K090342 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400". The FDA issued a decision of Substantially Equivalent on August 11, 2009. 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.