RAP Femoral Venous Cannulae

RAP Femoral Venous Cannulae is an FDA 510(k)-cleared medical device (K250283) 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 July 9, 2025. Regulation: 8.