BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    PD24130 Phoenix Atherectomy Catheter, 2.4mm X 130cm

    Reg #: 3003780911 · FEI: 3003780911 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASAHI INTECC (THAILAND) CO., LTD.
    Registration Number
    3003780911
    FEI Number
    3003780911
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    158/1 Moo 5, Bangkadi Idustrial Park, TIWANON ROAD, TAMBOL BANGKADI,
    City
    Amphur Muang Pathumthani Pathum Thani
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K211518

    Owner / Operator

    Firm Name
    ASAHI INTECC CO., LTD.
    Operator Number
    9051916
    Address
    3-100 Akatsuki-cho, --
    City
    Seto
    State
    Aichi
    Postal Code
    489-0071
    Country
    JP

    US Agent

    Business Name
    ASAHI INTECC USA, INC.
    Contact Name
    Yoshi Terai
    Address
    3002 Dow Ave Suite 212
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    949 7568636 ext. 501

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    PD24130 Phoenix Atherectomy Catheter, 2.4mm X 130cm P15149 Phoenix Atherectomy Catheter, 1.5mm X 149cm P15149K Phoenix Atherectomy System, 1.5mm X 149cm Kit PD24130K Phoenix Atherectomy System, 2.4mm X 130cm Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)