FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)

FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) is an FDA 510(k)-cleared medical device (K061332) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2006. Regulation: 8.