PS MEDICAL DELTA BURR HOLE VALVE

PS MEDICAL DELTA BURR HOLE VALVE is an FDA 510(k)-cleared medical device (K934545) 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 April 27, 1994. Regulation: 8.