510(k) K042481

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

K042481 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400". The FDA issued a decision of Substantially Equivalent on December 14, 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.