510(k) K802586

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE by American Heyer Schulte — Product Code JXG

K802586 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "AMERICAN HEYER-SCHULTE LOW PROFILE VALVE". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. American Heyer Schulte has at least 10 other 510(k) clearances on record.