TRIUMPH VTX WITH LIFEVALVE CATHETER

TRIUMPH VTX WITH LIFEVALVE CATHETER is an FDA 510(k)-cleared medical device (K032557) manufactured by Horizon Medical Products, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 2003. Regulation: 8.