FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K021547) manufactured by Jotec GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 2003. Regulation: 8.