Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K131778 |
Device Name |
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT |
Applicant |
MAQUET CARDIOVASCULAR LLC |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
MARYLOU INSINGA |
Correspondent |
MAQUET CARDIOVASCULAR LLC |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
MARYLOU INSINGA |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 06/17/2013 |
Decision Date | 11/14/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01113892
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|