PS MEDICAL VENTRICULOSTOMY KIT

PS MEDICAL VENTRICULOSTOMY KIT is an FDA 510(k)-cleared medical device (K915546) manufactured by Pudenz-Schulte Medical Research Corp.. 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 29, 1991. Regulation: 8.