Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K140008 |
Device Name |
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM |
Applicant |
Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Applicant Contact |
GARRY COURTNEY |
Correspondent |
Terumo Cardiovascular Systems Corporation |
125 BLUE BALL RD. |
ELKTON,
MD
21921
|
|
Correspondent Contact |
GARRY COURTNEY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/02/2014 |
Decision Date | 10/31/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|