Device Classification Name |
Clip, Implantable
|
510(k) Number |
K122276 |
Device Name |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
Applicant |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE |
WEST CHESTER,
OH
45069
|
|
Applicant Contact |
JAMES LUCKY |
Correspondent |
ATRICURE, INC. |
6217 CENTRE PARK DRIVE |
WEST CHESTER,
OH
45069
|
|
Correspondent Contact |
JAMES LUCKY |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/30/2012 |
Decision Date | 08/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|