Penumbra System (Modified 110 Aspiration Tubing)

Penumbra System (Modified 110 Aspiration Tubing) is an FDA 510(k)-cleared medical device (K182522) 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 October 11, 2018. Regulation: 8.