BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SwiftNINJA Microcatheter

    Reg #: 3002806337 · FEI: 3002806337 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Akita Sumitomo Bakelite Co., Ltd.
    Registration Number
    3002806337
    FEI Number
    3002806337
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27-4, Aza Nakajimashita, Souzen-machi, Tsuchizakiminato
    City
    Akita
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K161921

    Owner / Operator

    Firm Name
    SB-KAWASUMI LABORATORIES, INC.
    Operator Number
    8031539
    Address
    3-25-4 Tonomachi, Kawasaki-ku
    City
    Kawasaki-shi
    State
    Kanagawa
    Postal Code
    210-8602
    Country
    JP
    Correspondent
    Kenichi - Inamura

    US Agent

    Business Name
    SUMITOMO PLASTICS AMERICA, INC.
    Contact Name
    TAKAHITO ISHIKAWA
    Address
    4675 Stevens Creek Blvd Ste 101
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US
    Email
    [email protected]
    Phone
    408 3355883

    Products

    Device Name Product Code
    Catheter, Continuous Flush KRA

    Proprietary Names

    SwiftNINJA Microcatheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)