510(k) K233448

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set by Integra Lifesciences Production Corporation — Product Code JXG

K233448 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set". The FDA issued a decision of Substantially Equivalent on December 19, 2023. 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.