ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER

ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER is an FDA 510(k)-cleared medical device (K002603) manufactured by Zcv ,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 January 7, 2001. Regulation: 8.