Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter
|
510(k) Number |
K102596 |
Device Name |
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT |
Applicant |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. |
HUDSON,
NH
03051
|
|
Applicant Contact |
RAYMOND J KELLY |
Correspondent |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. |
HUDSON,
NH
03051
|
|
Correspondent Contact |
RAYMOND J KELLY |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 09/09/2010 |
Decision Date | 10/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|