PENUMBRA COIL SYSTEM/PENUMBRA COIL 400

PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 is an FDA 510(k)-cleared medical device (K120330) manufactured by Penumbra, 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 April 1, 2012. Regulation: 8.