BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOTWIRE RF Guidewire

    Reg #: 1424785 · FEI: 3003473212 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ACCUMEDIX, INC.
    Registration Number
    1424785
    FEI Number
    3003473212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    800 Liberty Drive
    City
    Libertyville
    State
    IL
    ZIP
    60048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240900

    Owner / Operator

    Firm Name
    ACCUMEDIX, INC.
    Operator Number
    9046081
    Address
    800 Liberty Drive, --
    City
    Libertyville
    State
    IL
    Postal Code
    60048
    Country
    US
    Correspondent
    Michele H Kupcso

    Products

    Device Name Product Code
    Catheter, Septostomy DXF

    Proprietary Names

    HOTWIRE RF Guidewire

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)