Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter
|
510(k) Number |
K881283 |
Device Name |
MEADOX INTRA-AORTIC GRAFT |
Applicant |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
MADELEINE KENDEFFY |
Correspondent |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
MADELEINE KENDEFFY |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 03/25/1988 |
Decision Date | 05/26/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|