Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is an FDA 510(k)-cleared medical device (K160533) 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 23, 2016. Regulation: 8.