510(k) K002481

ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 by Zcv ,Inc. — Product Code LDF

K002481 is an FDA 510(k) premarket notification submitted by Zcv ,Inc. for the device "ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3". The FDA issued a decision of Substantially Equivalent on December 7, 2000. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Zcv ,Inc. has at least 5 other 510(k) clearances on record.