ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 is an FDA 510(k)-cleared medical device (K991060) 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 April 5, 2000. Regulation: 8.