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

Manufacturer	Device Name	Date
K192125 AtriCure, Inc	Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen	2019-11-04
K191413 AtriCure, Inc	AtriClip LAA Exclusion System With Preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System With Preloaded V-Clip	2019-08-21
K190587 AtriCure, Inc	Coolrail Linear Pen	2019-07-24
K190151 AtriCure, Inc.	COBRA Fusion Ablation System	2019-02-25
K183065 AtriCure, Inc.	Coolrail Linear Pen	2018-12-04
K182565 AtriCure, Inc.	AtriCure CryoICE CryoSPHERE Cryoablation Probe	2018-11-09
K181474 AtriCure, Inc.	ArtiClip LAA Exclusion System	2018-06-28
K180138 AtriCure, Inc.	AtriCure CryoICE Cryo-ablation Probe (CRYO2)	2018-02-15
K180137 AtriCure, Inc.	AtriCure CryoICE Cryo-ablation Probe (CRYO3), AtriCure CryoICE CryoFORM Cryo-ablation Probe (CRYOF)	2018-02-15
K180010 AtriCure, Inc.	AtriClip FLEX-V	2018-01-31
K152337 ATRICURE, INC	CryoFORM CryoICE Cryoablation Probe	2016-03-22
K142441 ATRICURE, INC.	CryoICE Croablation Probe	2014-10-29
K110117 ATRICURE, INC.	ATRICURE BIPOLAR SYSTEM	2011-04-08
K101174 ATRICURE, INC.	ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2	2010-11-12

Latest Premarket Applications

PMA	Manufacturer	Device Name	Date
P100046S010	ATRICURE INC.	AtriCure Synergy Ablation System	2019-06-26
P100046S009	ATRICURE INC.	Synergy Ablation System	2018-12-31
P100046S007	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2016-12-14
P100046S008	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2016-10-05
P100046S003	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2015-08-26
P100046S006	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2015-02-12
P100046S005	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2014-10-22
P100046S004	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2014-06-13
P100046S002	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB	2013-06-14
P100046S001	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2012-08-15
P100046	ATRICURE INC.	ATRICURE SYNERGY ABLATION SYSTEM	2011-12-14

Latest De Novo Filings

De Novo	Manufacturer	Device Name	Date

GUDID Registrations

Device GUDID Device Name	Manufacturer	Date
00818354011135 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354011043 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354010893 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354010824 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354010756 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354016499 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354010558 Synergy™ Ablation System	ATRICURE, INC.	2019-11-27
00818354010503 Synergy™ Ablation System	ATRICURE, INC.	2019-11-27
00818354010473 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354010343 Isolator Surgical Ablation System	ATRICURE, INC.	2019-11-27
00818354015393 Subtle Cannula with Guide	ATRICURE, INC.	2019-11-27
00818354015379 Subtle Cannula with Guide	ATRICURE, INC.	2019-11-27
00818354015355 nContact RF Generator	ATRICURE, INC.	2019-11-27
00818354015331 nContact RF Generator	ATRICURE, INC.	2019-11-27
00818354015324 nContact RF Generator	ATRICURE, INC.	2019-11-27
00818354015317 nContact RF Generator	ATRICURE, INC.	2019-11-27
00818354015300 EPi-Sense Guided Coagulation System with VisiTrax	ATRICURE, INC.	2019-11-27
00818354015287 Numeris Tethered Coagulation System with VisiTrax®	ATRICURE, INC.	2019-11-27
00818354015249 EPi-Sense Guided Coagulation System with VisiTrax	ATRICURE, INC.	2019-11-27
00818354015201 EPi-Sense Guided Coagulation System with VisiTrax	ATRICURE, INC.	2019-11-27
00818354014761 Cardiac Cryosurgical System	ATRICURE, INC.	2019-11-01
00818354013474 LiV™ Instruments	ATRICURE, INC.	2019-10-23
00818354013375 LiV™ Instruments	ATRICURE, INC.	2019-10-23
00818354016796 cryoICE Cryoablation System	ATRICURE, INC.	2019-09-26
00818354013160 LiV™ Instruments	ATRICURE, INC.	2019-02-21
00818354016048 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354014396 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013887 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013832 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013825 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013801 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013795 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013788 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013771 LiV™ Instruments	ATRICURE, INC.	2018-12-21
00818354013764 LiV™ Instruments	ATRICURE, INC.	2018-12-21