Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K020143 |
Device Name |
VASOVIEW 5 HARVESTING CANNULA |
Applicant |
GUIDANT CORPORATION, CARDIAC SURGERY |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
ANNE SCHLAGENHAFT |
Correspondent |
N.V. KEMA |
P.O. BOX 9035 |
6800 ET ARNHEM |
ARNHEM,
NL
|
|
Correspondent Contact |
PETER N RUYS |
Regulation Number | 884.1720
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/16/2002 |
Decision Date | 02/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|