Device Classification Name |
Clip, Implantable
|
510(k) Number |
K091987 |
Device Name |
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP |
Applicant |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
ERIN E DALY |
Correspondent |
LEMAITRE VASCULAR, INC. |
63 2ND AVENUE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
ERIN E DALY |
Regulation Number | 878.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2009 |
Decision Date | 04/23/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|