RADIONICS BURR HOLE VALVE

RADIONICS BURR HOLE VALVE is an FDA 510(k)-cleared medical device (K970578) manufactured by Radionics, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 1997. Regulation: 8.