510(k) K152700

StrataMR Valves and Shunts by Medtronic Neurosurgery — Product Code JXG

K152700 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "StrataMR Valves and Shunts". The FDA issued a decision of Substantially Equivalent on April 7, 2016. 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.