INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK

INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK is an FDA 510(k)-cleared medical device (K251949) 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 February 4, 2026. Regulation: 8.