ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3


codes

Device Classification Name

electrode, pacemaker, temporary

510(k) Number K002687
Device Name ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
Original Applicant
ZYNERGY CARDIOVASCULAR, INC.
298 fernwood ave.
edison, 
NJ 
08837 -3839

Original Contact jing zhang
Regulation Number 870.3680
Classification Product Code
LDF  
Date Received 08/29/2000
Decision Date 11/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No