BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Fighter™ Guidewire

    Reg #: 3013023134 · FEI: 3013023134 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FMD. Co., Ltd.
    Registration Number
    3013023134
    FEI Number
    3013023134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-166 Shimoobari Nakashima
    City
    Komaki Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K151840

    Owner / Operator

    Firm Name
    FMD Co., Ltd.
    Operator Number
    10052039
    Address
    Sasazuka Daiichi Bldg. 8F, 1-57-7 Sasazuka, Shibuya-ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    151-0073
    Country
    JP
    Correspondent
    Mayumi Ito

    US Agent

    Business Name
    Far West Consulting, LLC
    Contact Name
    Max Bynum
    Address
    4768 Woodview Dr
    City
    Santa Rosa
    State
    CA
    ZIP
    95405
    Country
    US
    Email
    [email protected]
    Phone
    707 2900082

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX

    Proprietary Names

    Fighter™ Guidewire Marvel™ Guidewire Samurai™ Guidewire Stretch Extension Wire Samurai™ RC Guidewire

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device