Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K090987 |
Device Name |
VASCUTEK BRANCHED GELWEAVE |
Applicant |
VASCUTEK LTD. |
NEWMAINS AVE. |
INCHINNAN, RENFREWSHIRE,
GB
PA4 9RR
|
|
Applicant Contact |
KAREN KELSO |
Correspondent |
VASCUTEK LTD. |
NEWMAINS AVE. |
INCHINNAN, RENFREWSHIRE,
GB
PA4 9RR
|
|
Correspondent Contact |
KAREN KELSO |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 04/07/2009 |
Decision Date | 06/19/2009 |
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
|
|
|