PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX

PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX is an FDA 510(k)-cleared medical device (K133317) manufactured by Penumbra, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2014. Regulation: 8.