Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K013022 |
Device Name |
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS |
Applicant |
SULZER CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. |
AUSTIN,
TX
78752
|
|
Applicant Contact |
LISA PETERSON |
Correspondent |
SULZER CARBOMEDICS, INC. |
1300 EAST ANDERSON LN. |
AUSTIN,
TX
78752
|
|
Correspondent Contact |
LISA PETERSON |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 09/07/2001 |
Decision Date | 06/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|