SMARxT Tubing and Connectors

SMARxT Tubing and Connectors is an FDA 510(k)-cleared medical device (K233702) manufactured by LivaNova USA, 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 August 7, 2024. Regulation: 8.