BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ATRICURE, INC.

    Reg #: 3011706110 · FEI: 3011706110 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    88
    Establishment Types
    5
    Classifications
    19

    Registration Details

    Registration Name
    ATRICURE, INC.
    Registration Number
    3011706110
    FEI Number
    3011706110
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    7555 Innovation Way
    City
    Mason
    State
    OH
    ZIP
    45040
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111020
    PMA Number
    P100046

    Owner / Operator

    Firm Name
    ATRICURE, INC.
    Operator Number
    9045049
    Address
    7555 Innovation Way, --
    City
    Mason
    State
    OH
    Postal Code
    45040
    Country
    US
    Correspondent
    Janet Hillard

    Products

    Device Name Product Code
    Instrument, Manual, Surgical, General Use MDM
    Cannula, Surgical, General & Plastic Surgery GEA
    Lamp, Surgical FTD
    Dissector, Surgical, General & Plastic Surgery GDI
    Guide, Surgical, Instrument FZX
    Left Atrial Appendage Clip, Implantable PZX
    Cutter, Surgical FZT
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Device, Surgical, Cryogenic GXH
    Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation OCM
    Unit, Cryosurgical, Accessories GEH
    Instrument, Ligature Passing And Knot Tying HCF
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Clip, Implantable FZP
    Stand, Instrument, Ac-Powered, Ophthalmic HMF
    Instruments, Surgical, Cardiovascular DWS
    Catheter, Percutaneous DQY
    Wire, Guide, Catheter DQX
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    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 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 EndoCATH Occlusion Balloon AtriClip Gillinov-Cosgrove LAA Clip FindrWirz Guide Wire System AtriCure Multifunctional linear pen Isolator Synergy Access Isolator® Synergy™ EnCompass Clamp and Guide System (OLH, OSH, GPM100) AtriCure Coolrail Linear Pen AtriCure cryoICE BOX (ACM) Cobra Cable Cobra ElectroSurgical Unit AtriCure Cryo Module System CryoICE cryo-ablation probe AtriCure Cryo Module Numeris Guided Coagulation System with Visitrax AtriClip FLEX-V device AtriCure Isolator Synergy EnCapture Ablation System EPi-Sense® Guided Coagulation System AtriCure cryoICE cryoSPHERE Cryoablation System Atricure Glidepath Tape Gillinov-Cosgrove Selection Guide cryoICE cryoSPHERE cryoablation probes Numeris Coagulation System with Visitrax (Gen 3 with Tether) CRYO3 - AtriCure cryoICE cryo-ablation probe Gillinov-Cosgrove Clip LARIAT+ Suture Delivery Device AtriClip PRO-Mini LAA Exclusion System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Remanufacture Medical Device Repack or Relabel Medical Device