Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011706110

FEI Number

3011706110

Entity Name

ATRICURE, INC.

City/State/Country

Mason, OH, US

Establishment Address

7555 Innovation Way, Mason, OH 45040, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ATRICURE, INC. (Owner Number: 9045049)

Owner / Operator Contact Address

7555 Innovation Way, --, Mason, OH 45040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120857

PMA Number

N/A

All Registered Proprietary Names

TenSURE Suture Tightener Cannula with Balloon Elevator Lumitip Dissector Wolf GlidePath Dissector AtriClip FLEX-Mini LAA Exclusion System SureCUT Suture Cutter COBRA Fusion 50 Ablation System Kit COBRA Fusion 50 Ablation System COBRA Fusion Magnetic Retriever System Kit COBRA Fusion 150 Ablation System COBRA Fusion Pacing Recorder Adapter Cable COBRA Fusion 150 Ablation System Kit COBRA Fusion Magnetic Retriever Atricure Cryo Module System AtriCure cryoICE cryo-ablation probe (CRYO2) Synergy Ablation System Multifunctional Ablation Generator EPi-Sense Guided Coagulation Device with VisiTrax ACC2 AtriCure Cryosurgical Console LARIAT Suture Delivery Device; SofTIP Guide Cannula AtriCure Bipolar System Isolator pen AtriClip PRO2 LAA Exclusion System AtriClip LAA Exclusion System AtriClip PRO LAA Exclusion System AtriClip PRO-V LAA Exclusion System AtriClip Flex-V LAA Exclusion System AtriCure cryoICE cryo-ablation probe (CRYO2), AtriCure cryoICE cryoSPHERE Cryoablation System (CryoS/S-L) AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, PRO ACH2 - AtriClip LAA Exclusion System cryoICE cryoXT cryoablation probe ASCS - AtriCure System Cart - Simple Compart Cart ASCB2 - AtriCure System Cart - Basic ASCF - AtriCure System Cart - Fusion Isolator Linear Pen Coolrail Linear Pen Isolator Transpolar Pen Isolator Synergy Access Clamp Isolator Synergy EnCompass Clamp and Guide System Multifunctional Ablation Generator Isolator Synergy Surgical Ablation System AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, PRO2 LARIAT RS Suture Delivery Device AtriClip PROV LAA Exclusion System AtriCure cryoICE cryoFORM cryoablation probe (CRYOF) SI Retractor Blades, Robotic SI Retractor Blades Hex Posts Window Access SI Retractor Body Window Access SI Retractor Body, Robotic Atrial Rakes Atrial Lift Blades Table Mount Instrument Holders Hercules Stabilizer Arm LiV Instruments Blade Introduction Forceps Aortic Valve Assistants Atrial Lift System Atrial Lift Blade Holders Soft Tissue Atraumatic Retractors (STARs) AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure Coolrail linear pen AtriClip LAA Exclusion System EndoCATH Occlusion Balloon AtriClip Gillinov-Cosgrove LAA Clip FindrWirz Guide Wire System AtriCure Multifunctional linear pen AtriCure Bipolar System Isolator Synergy Access AtriCure Bipolar System Isolator® Synergy EnCompass Clamp and Guide System (OLH, OSH, GPM100) AtriCure Coolrail Linear Pen COBRA Fusion 150 Ablation System COBRA Fusion 50 Ablation System COBRA Fusion Magnetic Retriever AtriCure cryoICE BOX (ACM) Cobra Cable Cobra ElectroSurgical Unit AtriCure Cryo Module System CryoICE cryo-ablation probe AtriCure Cryo Module AtriClip LAA Exclusion System Numeris Guided Coagulation System with Visitrax AtriCure Coolrail linear pen EPi-Sense Guided Coagulation Device with VisiTrax

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-11-07
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-11-07
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2011-06-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2011-06-23
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-08-02
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-08-02
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-07
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2015-01-02
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2015-08-06
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2018-02-21
OCM	Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2012-08-03
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2016-11-07
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2008-03-10
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2019-11-07
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-11-07
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2021-06-04
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2020-01-13
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-01-16
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-01-16
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2021-01-05
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2012-10-22
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2015-04-03
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2025-04-21
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2008-03-10
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2023-02-06
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-03-25
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-11-07
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2019-11-07
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-03-25
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2016-03-25
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2015-01-02
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2018-02-21
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-03-13
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2021-03-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-11-07
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2013-07-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-07
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2015-08-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-11
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2011-04-18
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2025-07-29
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2020-02-28
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-03-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-01-02
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2025-01-02
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2015-01-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-01-02
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2011-06-23
PZX	Left Atrial Appendage Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2018-07-17
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2016-11-07
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2012-10-22
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2016-11-07

Official Correspondent

Janet Hillard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATRICURE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011788769	AtriCure - Minneapolis	Minnetonka, MN, US
3020954746	AtriCure, Inc.	Pleasanton, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K120857	Ncontact Surgical, Inc.	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	2012-11-13
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011706110. Last updated year: 2026. Please use registration number 3011706110 when referencing this establishment in official correspondence.