Device Classification Name |
graft, vascular, synthetic/biologic composite
|
510(k) Number |
K052302 |
Device Name |
HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION |
Applicant |
BOSTON SCIENTIFIC CORP. |
2 SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
JENNIFER BOLTON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2 SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
JENNIFER BOLTON |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 08/24/2005 |
Decision Date | 09/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|