Device Classification Name |
electrode, pacing and cardioversion, temporary, epicardial
|
510(k) Number |
K020701 |
Device Name |
SYNCRUS INTERNAL CARDIOVERSION SYSTEM |
Applicant |
GUIDANT CORPORATION, CARDIAC SURGERY |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
DEBBIE COGAN |
Correspondent |
GUIDANT CORPORATION, CARDIAC SURGERY |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
DEBBIE COGAN |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 03/04/2002 |
Decision Date | 05/24/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|