Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K101274 |
Device Name |
VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM |
Applicant |
MAQUET CARDIOVASCULAR, LLC |
170 BAYTECH DRIVE |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
MARK H SMITH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/06/2010 |
Decision Date | 06/11/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|