EMBOL-X INTRODUCER, MODEL CF00200

EMBOL-X INTRODUCER, MODEL CF00200 is an FDA 510(k)-cleared medical device (K002973) manufactured by Embol-X, 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 April 25, 2001. Regulation: 8.