Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen

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 Isolator Transpolar Pen, Isolator Long Pen Tt, Isolator Linear Pen.

Pre-market Notification Details

Device IDK192125
501k NumberK192125
Device Name:Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
ClassificationSurgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Applicant AtriCure, Inc 7555 Innovation Way Mason,  OH  45040
ContactJohnathon Mcelwee
CorrespondentKristen Evenson
AtriCure, Inc 7555 Innovation Way Mason,  OH  45040
Product CodeOCL  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
501k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2019-11-04

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