510(k) K221840

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves by Integra Lifesciences Production Corporation — Product Code JXG

K221840 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves". The FDA issued a decision of Substantially Equivalent on October 14, 2022. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Lifesciences Production Corporation has at least 8 other 510(k) clearances on record.