RIVETTI-LEVINSON INSTRALUMINAL SHUNT

RIVETTI-LEVINSON INSTRALUMINAL SHUNT is an FDA 510(k)-cleared medical device (K972261) manufactured by Integra Neurocare, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 1997. Regulation: 8.