BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TORAY INTERNATIONAL AMERICA INC.

    Reg #: 1649869 · FEI: 3001632632 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    TORAY INTERNATIONAL AMERICA INC.
    Registration Number
    1649869
    FEI Number
    3001632632
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    140 CYPRESS STATION DR., SUITE 210
    City
    HOUSTON
    State
    TX
    ZIP
    77090
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220881
    PMA Number
    P910054

    Owner / Operator

    Firm Name
    TORAY INTERNATIONAL AMERICA INC.
    Operator Number
    2435106
    Address
    140 CYPRESS STATION DR., SUITE 210
    City
    Houston
    State
    TX
    Postal Code
    77090
    Country
    US

    Products

    Device Name Product Code
    Balloon Aortic Valvuloplasty OZT
    Shield, Eye, Radiological IWS
    Catheter, Percutaneous (Valvuloplasty) MAD
    Wire, Guide, Catheter DQX

    Proprietary Names

    INOUE BALLOON A XR-700 Inoue Balloon catheter Torayguide Guidewire

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198