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ATRICURE, INC.

United States·US-MF-000002974

Last updated September 17, 2026

Information

Country: United States
Address: 7555, Innovation Way, Mason, United States
Website: www.atricure.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 866-349-2342
PRRC Contact: Scott Ehlert
EUDAMED SRN: US-MF-000002974
FDA FEI Number: 3011706110
DUNS Number: 006133784

Catalogue (441)

Page 9 of 9

Device	Model / Reference	Registries	Class	Status
Atricure Bipolar System	K043579	FDA 510(k)	Class II	Active
Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)	K221358	FDA 510(k)	Class II	Active
AtriCure cryoICE BOX (ACM)	K243157	FDA 510(k)	Class II	Active
AtriClip PRO-Mini LAA Exclusion System (PROM)	K243860	FDA 510(k)	Class II	Active
Atricure Cryo Module System	K112072	FDA 510(k)	Class II	Active
AtriCure cryoICE cryo-ablation probe (CRYO2)	K180138	FDA 510(k)	Class II	Active
AtriCure cryoICE cryoSPHERE cryoablation probe	K182565	FDA 510(k)	Class II	Active
cryoICE croablation probe	K142441	FDA 510(k)	Class II	Active
Coolrail Linear Pen	K190587	FDA 510(k)	Class II	Active
Atricure Cryo Module System (acm, Cryo1, And Cryoice)	K121507	FDA 510(k)	Class II	Active
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)	K233170	FDA 510(k)	Class II	Active
Isolator Multifunctional Linear Pen	K163408	FDA 510(k)	Class II	Active
AtriClip FLEX-V	K180010	FDA 510(k)	Class II	Active
Atricure Dissector	K041681	FDA 510(k)	Class II	Active
Atricure Cryo Module System	K140058	FDA 510(k)	Class II	Active
Atricure Bipolar Coagulation System	K011722	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip	K150996	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip	K153500	FDA 510(k)	Class II	Active
Atricure Bipolar System, Models Asu1, Asu2, Asu3, Lhp1, Lhp2, Rhp1	K020919	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)	K233407	FDA 510(k)	Class II	Active
Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)	K252056	FDA 510(k)	Class II	Active
Atricure Transpolar System	K052893	FDA 510(k)	Class II	Active
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen	K192125	FDA 510(k)	Class II	Active
Atriclip Gillinov-Cosgrove Laa Clip	K131107	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with Preloaded PRO·V Clip	K173031	FDA 510(k)	Class II	Active
COBRA Fusion Ablation System	K190151	FDA 510(k)	Class II	Active
Atriclip Laa Exclusion System With Preloaded Gillinov-Cosgrove Clip	K142120	FDA 510(k)	Class II	Active
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)	K200697	FDA 510(k)	Class II	Active
EPi-Ease Epicardial Access Device (EAS)	K233959	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip	K191413	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip	K160454	FDA 510(k)	Class II	Active
EPi-Sense Guided Coagulation System with VisiTrax	K193162	FDA 510(k)	Class II	Active
cryoFORM cryoICE cryoablation probe	K152337	FDA 510(k)	Class II	Active
Atricure Coolrail Linear Pen	K073605	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System	K210293	FDA 510(k)	Class II	Active
cryoICE® System	A001150-14	EUDAMED	Class I	Active
cryoICE® System Footswitch	A001361	EUDAMED	Class I	Active
cryoICE® System	A001150-13	EUDAMED	Class I	Active
Coagulation RF Cable	CSK-2000-3	EUDAMED	Class I	Active
EPi-Sense ST Coagulation System	P200002	FDA PMA	Class III	Active
Synergy Ablation System	K063630	FDA PMAFDA UDI	Class III	Active

Related Companies

Authorised Representatives

AtriCure Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 28, 2023	Z-0927-2024	—	open, classified	AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
Nov 28, 2023	Z-0928-2024	—	open, classified	AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
May 29, 2019	Z-1887-2019	—	terminated	The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.
Jan 22, 2019	Z-0831-2019	—	terminated	There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Jan 22, 2019	Z-0830-2019	—	terminated	There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Jan 22, 2019	Z-0832-2019	—	terminated	There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Jan 22, 2019	Z-0829-2019	—	terminated	There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
Nov 30, 2016	Z-1148-2017	—	terminated	A complaint of the PRO2 jaw breaking prior to surgery being performed.
Sep 22, 2016	Z-0377-2017	—	terminated	There is a potential for a component failure of the device which could necessitate medical intervention.
Sep 22, 2016	Z-0653-2017	—	terminated	Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
Nov 21, 2014	Z-0895-2015	—	terminated	Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
Jan 23, 2014	Z-1209-2014	—	terminated	The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Jan 14, 2013	Z-0912-2013	—	terminated	Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.