Penumbra System 3D Revascularization Device

Penumbra System 3D Revascularization Device is an FDA 510(k)-cleared medical device (K190464) 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 25, 2019. Regulation: 8.