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    FDA Registration Active 🇺🇸 United States

    435-06076 – CORE Integrated Software v3.2.2 Installation Kit

    Reg #: 3008363989 · FEI: 3008363989 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Volcano Corporation
    Registration Number
    3008363989
    FEI Number
    3008363989
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3721 Valley Centre Dr Ste 500
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111706

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2939520
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Computer, Blood-Pressure DSK
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    435-06076 – CORE Integrated Software v3.2.2 Installation Kit 435-06071 – s5/s5x Software v3.2.2 Installation Kit 435-06074 – s5i/s5ix Software v3.2.2 Installation Kit 435-06073 – s5 Family Software v3.2.2 Update Kit 411-01001 – Bedside Utility Box

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility