BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AltaTrack Guidewire

    Reg #: 3008363989 · FEI: 3008363989 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    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
    K201081

    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
    Catheter, Intravascular, Diagnostic DQO
    Wire, Guide, Catheter DQX
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    AltaTrack Guidewire AltaTrack equipment R1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198