FIBERNET EMBOLIC PROTECTION SYSTEM

FIBERNET EMBOLIC PROTECTION SYSTEM is an FDA 510(k)-cleared medical device (K082348) manufactured by Lumen Biomedical, 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 November 17, 2008. Regulation: 8.