510(k) K261004

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) by Integra Lifesciences Production Corporation — Product Code JXG

K261004 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)". The FDA issued a decision of Substantially Equivalent on June 23, 2026. 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.