INDIGO® Aspiration System – INDIGO Link

INDIGO® Aspiration System – INDIGO Link is an FDA 510(k)-cleared medical device (K260599) 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 23, 2026. Regulation: 8.