ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER


information about

Device Classification Name

electrode, pacemaker, temporary

510(k) Number K002603
Device Name ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
Original Applicant
ZCV ,INC.
298 fernwood ave.
edison, 
NJ 
08837

Original Contact jing zhang
Regulation Number 870.3680
Classification Product Code
LDF  
Date Received 08/22/2000
Decision Date 01/08/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No