FOCUS PC BALLOON DILATATION CATHETER

FOCUS PC BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K954313) manufactured by Cardio-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 November 30, 1995. Regulation: 8.