BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Solex 7 Intravascular Heat Exchange Catheter

    Reg #: 3010617000 · FEI: 3003793491 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ZOLL Circulation, Inc.
    Registration Number
    3010617000
    FEI Number
    3003793491
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2000 Ringwood Ave
    City
    San Jose
    State
    CA
    ZIP
    95131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213031

    Owner / Operator

    Firm Name
    ZOLL Medical Corporation
    Operator Number
    1220908
    Address
    269 MILL ROAD
    City
    Chelmsford
    State
    MA
    Postal Code
    01824
    Country
    US

    Products

    Device Name Product Code
    System, Hypothermia, Intravenous, Cooling NCX

    Proprietary Names

    Solex 7 Intravascular Heat Exchange Catheter Thermogard XP Console Quattro Intravascular Heat Exchange Catheter Start-Up Kit ICY Intravascular Heat Exchange Catheter Cool Line Intravascular Heat Exchange Catheter Coolgard 3000 Console

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device