Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

About This 510(k) Submission

K233448 is an FDA 510(k) clearance for the Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set, 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 December 19, 2023, 60 days after receiving the submission on October 20, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.