FOCUS-PV BALLOON DILATATION CATHETER

FOCUS-PV BALLOON DILATATION CATHETER is an FDA 510(k)-cleared medical device (K971577) 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 17, 1997. Regulation: 8.