BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Traxcess 14 SELECT Guidewire

    Reg #: 3009092139 · FEI: 3009092139 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Yokowo Co., Ltd
    Registration Number
    3009092139
    FEI Number
    3009092139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1112 Kanohara
    City
    Tomioka Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K200547

    Owner / Operator

    Firm Name
    Yokowo Co., Ltd.
    Operator Number
    10047481
    Address
    5-11 Takinogawa, 7-Chome
    City
    Kita-ku
    State
    Tokyo
    Postal Code
    114-8515
    Country
    JP
    Correspondent
    Koichi Tachikawa

    US Agent

    Business Name
    YOKOWO AMERICA CORPORATION
    Contact Name
    Isao Tokuda
    Address
    1711 W Greentree Dr Ste 115
    City
    Tempe
    State
    AZ
    ZIP
    85284
    Country
    US
    Email
    [email protected]
    Phone
    602 8888331 ext. 100

    Products

    Device Name Product Code
    Guide, Wire, Catheter, Neurovasculature MOF
    Wire, Guide, Catheter DQX

    Proprietary Names

    Traxcess 14 SELECT Guidewire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)