BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER

BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K060960) manufactured by Boston Scientific Corporation. 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 11, 2006. Regulation: 8.