FOCUS BALLOON DILATATION CATHETER

FOCUS BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K952064) manufactured by Cardiovascular Dynamics, 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 June 20, 1995. Regulation: 8.