BEUDAMED
    FDA Registration Active 🇺🇸 United States

    803521-001, 802745-001 – ComboMap System

    Reg #: 2939520 · FEI: 2939520 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    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
    K082229

    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
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    803521-001, 802745-001 – ComboMap System 803523-001 – ComboMap Cart Kit 806426-008 – ComboMap Software v1.9 Document Kit 807062-001 – ComboMap Sterile Cover 806426-004 – ComboMap Software v1.9 Upgrade Kit 806426-012 – ComboMap Software v2.1 Upgrade Kit

    Establishment Types

    Manufacture Medical Device