BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AtriClip PRO LAA Exclusion System

    Reg #: 3011706110 · FEI: 3011706110 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    ATRICURE, INC.
    Registration Number
    3011706110
    FEI Number
    3011706110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7555 Innovation Way
    City
    Mason
    State
    OH
    ZIP
    45040
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233407

    Owner / Operator

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

    Products

    Device Name Product Code
    Left Atrial Appendage Clip, Implantable PZX
    Guide, Surgical, Instrument FZX

    Proprietary Names

    AtriClip PRO LAA Exclusion System AtriClip PRO2 LAA Exclusion System AtriClip Flex-V LAA Exclusion System AtriClip LAA Exclusion System AtriClip PRO-V LAA Exclusion System

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device