510(k) K991060

ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 by Zcv ,Inc. — Product Code DRF

K991060 is an FDA 510(k) premarket notification submitted by Zcv ,Inc. for the device "ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000". The FDA issued a decision of Substantially Equivalent on April 6, 2000. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Zcv ,Inc. has at least 5 other 510(k) clearances on record.