BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOTWIRE RF GUIDEWIRE

    Reg #: 3029895042 · FEI: 3029895042 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ATRAVERSE MEDICAL
    Registration Number
    3029895042
    FEI Number
    3029895042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2611 S Coast Hwy 101 # 204
    City
    Cardiff by the Sea
    State
    CA
    ZIP
    92007
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240900

    Owner / Operator

    Firm Name
    Atraverse Medical
    Operator Number
    10089209
    Address
    2611 S Coast Hwy 101 # 204
    City
    Cardiff by the Sea
    State
    CA
    Postal Code
    92007
    Country
    US
    Correspondent
    Robert Carmona

    Products

    Device Name Product Code
    Catheter, Septostomy DXF

    Proprietary Names

    HOTWIRE RF GUIDEWIRE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility