Device Classification Name |
clip, implantable
|
510(k) Number |
K153500 |
Device Name |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip |
Applicant |
Atricure, Inc. |
6217 Centre Park Drive |
West Chester,
OH
45069
|
|
Applicant Contact |
Jonathan McElwee |
Correspondent |
Atricure, Inc. |
6217 Centre Park Drive |
West Chester,
OH
45069
|
|
Correspondent Contact |
Jonathan McElwee |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 12/07/2015 |
Decision Date | 01/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|