Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]

Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] is an FDA 510(k)-cleared medical device (K142870) 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 25, 2015. Regulation: 8.