Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K052274 |
Device Name |
GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 |
Applicant |
GUIDANT CORPORATION |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
M. LAURIE WONG |
Correspondent |
GUIDANT CORPORATION |
3200 LAKESIDE DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
M. LAURIE WONG |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/22/2005 |
Decision Date | 09/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|