Indigo Aspiration System Lightning Aspiration Tubing

Indigo Aspiration System Lightning Aspiration Tubing is an FDA 510(k)-cleared medical device (K200771) 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 21, 2020. Regulation: 8.