Penumbra 3D Revascularization Device

Penumbra 3D Revascularization Device is an FDA 510(k)-cleared medical device (K162901) 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 April 19, 2017. Regulation: 8.