PRIMUS STENT AND DELIVERY SYSTEM

PRIMUS STENT AND DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K043243) manufactured by Ev3, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2004. Regulation: 8.