BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    CARTO 3 System and Accessories v7

    Reg #: 3008203003 · FEI: 3008203003 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Biosense Webster (Israel), Ltd.
    Registration Number
    3008203003
    FEI Number
    3008203003
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Hatnufa Street
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K191660

    Owner / Operator

    Firm Name
    BIOSENSE WEBSTER, INC.
    Operator Number
    9044811
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Maria Jose Arana

    US Agent

    Business Name
    Biosense Webster Inc.
    Contact Name
    Maria Jose Arana
    Address
    31 Technology Dr. Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    619 5657045

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    CARTO 3 System and Accessories v7

    Establishment Types

    Manufacture Medical Device