Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K210477 |
Device Name |
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE |
Applicant |
AtriCure Inc. |
7555 Innovation Way |
Mason,
OH
45040
|
|
Applicant Contact |
Melissa Smallwood |
Correspondent |
AtriCure Inc. |
7555 Innovation Way |
Mason,
OH
45040
|
|
Correspondent Contact |
Melissa Smallwood |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 02/19/2021 |
Decision Date | 07/26/2021 |
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
|
|
|