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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 8 of 9

Device	Model / Reference	Registries	Class	Status
SureCUT	50-01	FDA UDI	Class I	Active
LiV™ Instruments	001-340-7802	FDA UDI	Class I	Active
AtriCure System Cart	ASCC	FDA UDI	Class I	Active
AtriCure Window Access SI Retractor	001-400-400	FDA UDI	Class I	Active
AtriCure cryoICE cryoSPHERE+ Cryoablation System	CRYOSP-L	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7825L	FDA UDI	Class I	Active
LiV™ Instruments	001-340-7800	FDA UDI	Class I	Active
EndoCATH	2006	FDA UDI	Class II	Active
AtriClip® PRO•V™ LAA Exclusion System	PROV50	FDA UDI	Class II	Active
AtriCure Atrial Lift System	001-401-505	FDA UDI	Class I	Active
EPi-Sense ST Coagulation Device	EPiST	FDA UDI	Class III	Active
AtriClip® PRO•V™ LAA Exclusion System	PROV40	FDA UDI	Class II	Active
AtriCure cryoICE cryoSPHERE Cryoablation System	CRYOS	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7840	FDA UDI	Class I	Active
LiV™ Instruments	001-340-7821S	FDA UDI	Class I	Active
Cardiac Cryosurgical System	3004	FDA UDI	Class II	Active
Cardiac Cryosurgical System	3014	FDA UDI	Class II	Active
SofTIP	60-02	FDA UDI	Class II	Active
Electrosurgical Unit	001-604-4810B	FDA UDI	Class II	Active
LiV™ Instruments	001-340-7835	FDA UDI	Class I	Active
TenSURE	80-02	FDA UDI	Class I	Active
AtriCure SI Retractor Blade	001-400-172	FDA UDI	Class I	Active
AtriCure System Cart	ASCB2	FDA UDI	Class I	Active
AtriClip® PRO•V™ LAA Exclusion System	PROV35	FDA UDI	Class II	Active
nContact RF Generator	CSK-2010	FDA UDI	Class II	Active
Ablation Sensing Unit	FSW2	FDA UDI	Class III	Active
LiV™ Instruments	001-340-7499	FDA UDI	Class I	Active
Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model Oll2, Osl2, Emr2, Eml2	K101174	FDA 510(k)	Class II	Active
Isolator Linear Pen	K130521	FDA 510(k)	Class II	Active
Atricure Cryo Module	K111042	FDA 510(k)	Class II	Active
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE	K210477	FDA 510(k)	Class II	Active
Atricure Cryo Module System; cryoICE cryoablation probe	K142203	FDA 510(k)	Class II	Active
AtriCure Isolator® Synergy™ Surgical Ablation System	K211311	FDA 510(k)	Class II	Active
Atricure Bipolar System	K110117	FDA 510(k)	Class II	Active
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)	K172742	FDA 510(k)	Class II	Active
cryoICE cryoXT cryoablation probe (cryoXT)	K250371	FDA 510(k)	Class II	Active
Coolrail Linear Pen	K183065	FDA 510(k)	Class II	Active
Coolrail Linear Pen Model Mcri	K122611	FDA 510(k)	Class II	Active
Atricure Isolator Transpolar Pen System, Models Asu2, Max1, Max2 And Asb1	K061593	FDA 510(k)	Class II	Active
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)	K180137	FDA 510(k)	Class II	Active
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip	K163261	FDA 510(k)	Class II	Active
Atricure Dissector	K111020	FDA 510(k)	Class II	Active
AtriClip FLEX-Mini LAA Exclusion System (ACHM)	K234125	FDA 510(k)	Class II	Active
ArtiClip LAA Exclusion System	K181474	FDA 510(k)	Class II	Active
Atriclip Laa Exclusion System With Preloaded Gillinov-Cosgrove Clip	K122276	FDA 510(k)	Class II	Active
Isolator Synergy EnCapture Ablation System (EMH)	K234151	FDA 510(k)	Class II	Active
Atricure Isolator Transpolar Pen	K050459	FDA 510(k)	Class II	Active
Atricure Cryo1 Cryo-Ablation Probe	K082074	FDA 510(k)	Class II	Active
Atriclip Laa Exclusion System With Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various Laa0	K093679	FDA 510(k)	Class II	Active
Multifunctional Linear Pen	K100501	FDA 510(k)	Class II	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.