Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K211311 |
Device Name |
AtriCure Isolator® Synergy™ Surgical Ablation System |
Applicant |
AtriCure, Inc. |
7555 Innovation Way |
Mason,
OH
45040
|
|
Applicant Contact |
Jon McElwee |
Correspondent |
AtriCure, Inc. |
7555 Innovation Way |
Mason,
OH
45040
|
|
Correspondent Contact |
Jon McElwee |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/30/2021 |
Decision Date | 05/28/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|