Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter
|
510(k) Number |
K130016 |
Device Name |
LIFESPAN EPTFE VASCULAR GRAFT |
Applicant |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
XIANG ZHANG |
Correspondent |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
XIANG ZHANG |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 01/01/2013 |
Decision Date | 02/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|