Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

About This 510(k) Submission

K233445 is an FDA 510(k) clearance for the Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Integra Lifesciences Production Corporation (Mansfield, US). The FDA issued a Cleared decision on January 17, 2024, 90 days after receiving the submission on October 19, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.