510(k) K190174

Miethke Shunt System GAV 2.0 and SA 2.0 Valves by Aesculap, Inc. — Product Code JXG

K190174 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Miethke Shunt System GAV 2.0 and SA 2.0 Valves". The FDA issued a decision of Substantially Equivalent on July 5, 2019. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Aesculap, Inc. has at least 10 other 510(k) clearances on record.