AtriCure Isolator® Synergy™ Surgical Ablation System

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

AtriCure, Inc.

The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Isolator® Synergy™ Surgical Ablation System.

Pre-market Notification Details

Device IDK211311
510k NumberK211311
Device Name:AtriCure Isolator® Synergy™ Surgical Ablation System
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant AtriCure, Inc. 7555 Innovation Way Mason,  OH  45040
ContactJon Mcelwee
CorrespondentJon Mcelwee
AtriCure, Inc. 7555 Innovation Way Mason,  OH  45040
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-30
Decision Date2021-05-28

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