Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K043579 |
Device Name |
ATRICURE BIPOLAR SYSTEM |
Applicant |
ATRICURE, INC. |
6033 SCHUMACHER PARK DR. |
WEST CHESTER,
OH
45069
|
|
Applicant Contact |
ELSA C ABRUZZO, RAC |
Correspondent |
ATRICURE, INC. |
6033 SCHUMACHER PARK DR. |
WEST CHESTER,
OH
45069
|
|
Correspondent Contact |
ELSA C ABRUZZO, RAC |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/28/2004 |
Decision Date | 07/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|