Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K955230 |
Device Name |
VASCUTEK GELSOFT PLUS VASCULAR GRAFT |
Applicant |
VASCUTEK LTD. |
1300 EAST ANDERSON LN. |
AUSTIN,
TX
78752
|
|
Applicant Contact |
TEENA M AUGOSTINO |
Correspondent |
VASCUTEK LTD. |
1300 EAST ANDERSON LN. |
AUSTIN,
TX
78752
|
|
Correspondent Contact |
TEENA M AUGOSTINO |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 11/14/1995 |
Decision Date | 02/09/1996 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|