510(k) K033704

MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS by Vygon Us, LLC — Product Code JXG

K033704 is an FDA 510(k) premarket notification submitted by Vygon Us, LLC for the device "MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS". The FDA issued a decision of Substantially Equivalent on May 27, 2004. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Vygon Us, LLC has 2 other 510(k) clearances on record.