HARMAC BALLOON WEDGE PRESSURE CATHETER

HARMAC BALLOON WEDGE PRESSURE CATHETER is an FDA 510(k)-cleared medical device (K963335) manufactured by Harmac Medical Products, 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 October 15, 1997. Regulation: 8.