510(k) K233445

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter by Integra Lifesciences Production Corporation — Product Code JXG

K233445 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter". The FDA issued a decision of Substantially Equivalent on January 17, 2024. 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.