AtriCure, Inc

FDA Filings

This page includes the latest FDA filings for AtriCure, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
AtriCure, Inc
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen2019-11-04
AtriCure, Inc
AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System With Preloaded V-Clip2019-08-21
AtriCure, Inc
Coolrail Linear Pen2019-07-24
AtriCure, Inc.
COBRA Fusion Ablation System2019-02-25
AtriCure, Inc.
Coolrail Linear Pen2018-12-04
AtriCure, Inc.
AtriCure CryoICE CryoSPHERE Cryoablation Probe2018-11-09
AtriCure, Inc.
ArtiClip LAA Exclusion System2018-06-28
AtriCure, Inc.
AtriCure CryoICE Cryo-ablation Probe (CRYO2)2018-02-15
AtriCure, Inc.
AtriCure CryoICE Cryo-ablation Probe (CRYO3), AtriCure CryoICE CryoFORM Cryo-ablation Probe (CRYOF)2018-02-15
AtriCure, Inc.
AtriClip FLEX-V2018-01-31
ATRICURE, INC
CryoFORM CryoICE Cryoablation Probe2016-03-22
ATRICURE, INC.
CryoICE Croablation Probe2014-10-29
ATRICURE, INC.
ATRICURE BIPOLAR SYSTEM2011-04-08
ATRICURE, INC.
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML22010-11-12

Latest Premarket Applications

PMAManufacturerDevice NameDate
ATRICURE INC.
AtriCure Synergy Ablation System2019-06-26
ATRICURE INC.
Synergy Ablation System2018-12-31
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2016-12-14
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2016-10-05
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2015-08-26
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2015-02-12
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2014-10-22
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2014-06-13
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB2013-06-14
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2012-08-15
ATRICURE INC.
ATRICURE SYNERGY ABLATION SYSTEM2011-12-14

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Synergy™ Ablation System
ATRICURE, INC.2019-11-27
Synergy™ Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Isolator Surgical Ablation System
ATRICURE, INC.2019-11-27
Subtle Cannula with Guide
ATRICURE, INC.2019-11-27
Subtle Cannula with Guide
ATRICURE, INC.2019-11-27
nContact RF Generator
ATRICURE, INC.2019-11-27
nContact RF Generator
ATRICURE, INC.2019-11-27
nContact RF Generator
ATRICURE, INC.2019-11-27
nContact RF Generator
ATRICURE, INC.2019-11-27
EPi-Sense Guided Coagulation System with VisiTrax
ATRICURE, INC.2019-11-27
Numeris Tethered Coagulation System with VisiTrax®
ATRICURE, INC.2019-11-27
EPi-Sense Guided Coagulation System with VisiTrax
ATRICURE, INC.2019-11-27
EPi-Sense Guided Coagulation System with VisiTrax
ATRICURE, INC.2019-11-27
Cardiac Cryosurgical System
ATRICURE, INC.2019-11-01
LiV™ Instruments
ATRICURE, INC.2019-10-23
LiV™ Instruments
ATRICURE, INC.2019-10-23
cryoICE Cryoablation System
ATRICURE, INC.2019-09-26
LiV™ Instruments
ATRICURE, INC.2019-02-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21
LiV™ Instruments
ATRICURE, INC.2018-12-21

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.