BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OmniWire Pressure Guide Wire

    Reg #: 2939520 · FEI: 2939520 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VOLCANO CORPORATION
    Registration Number
    2939520
    FEI Number
    2939520
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2451 Mercantile Drive
    City
    Rancho Cordova
    State
    CA
    ZIP
    95742
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192886

    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
    Transducer, Pressure, Catheter Tip DXO
    Wire, Guide, Catheter DQX

    Proprietary Names

    OmniWire Pressure Guide Wire

    Establishment Types

    Manufacture Medical Device