BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ILUMIEN Systems with AptiVue Software Version D.3

    Reg #: 2024168 · FEI: 2024168 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT VASCULAR
    Registration Number
    2024168
    FEI Number
    2024168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    26531 YNEZ RD.
    City
    Temecula
    State
    CA
    ZIP
    92591
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192267

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    System, Imaging, Optical Coherence Tomography (Oct) NQQ
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    ILUMIEN Systems with AptiVue Software Version D.3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198