Device Classification Name |
electrode, pacemaker, temporary
|
510(k) Number |
K002481 |
Device Name |
ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 |
Applicant |
ZCV ,INC. |
298 FERNWOOD AVE. |
EDISON,
NJ
08837
|
|
Applicant Contact |
JING ZHANG |
Correspondent |
ZCV ,INC. |
298 FERNWOOD AVE. |
EDISON,
NJ
08837
|
|
Correspondent Contact |
JING ZHANG |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 08/14/2000 |
Decision Date | 12/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|