Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K122138 |
Device Name |
ATRIUM FLIXENE IFG VASCULAR GRAFT |
Applicant |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR |
HUDSON,
NH
03051
|
|
Applicant Contact |
MEGAN MCCAGH |
Correspondent |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR |
HUDSON,
NH
03051
|
|
Correspondent Contact |
MEGAN MCCAGH |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 07/19/2012 |
Decision Date | 08/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|