Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is an FDA 510(k)-cleared medical device (K233448) manufactured by Integra Lifesciences Production Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 2023. Regulation: 8.