CVD PERIFLOW(TM) BALLOON DILATATION CATHETER

CVD PERIFLOW(TM) BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K945943) 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 February 23, 1995. Regulation: 8.