510(k) K082127

STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 by Medtronic Neurosurgery — Product Code JXG

K082127 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635". The FDA issued a decision of Substantially Equivalent on August 27, 2008. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.