BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Stealth 360 Peripheral Orbital Atherectomy System

    Reg #: 3004091615 · FEI: 3004091615 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Vascular Netherlands
    Registration Number
    3004091615
    FEI Number
    3004091615
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Argonstraat 1
    City
    Heerlen Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K203008

    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

    US Agent

    Business Name
    Abbott Vascular
    Contact Name
    Keith Krohn
    Address
    26531 Ynez Road, M/S TCC-215
    City
    Temecula
    State
    CA
    ZIP
    92591
    Country
    US
    Email
    [email protected]
    Phone
    951 9143324

    Products

    Device Name Product Code
    Catheter, Peripheral, Atherectomy MCW

    Proprietary Names

    Stealth 360 Peripheral Orbital Atherectomy System DiamondBack 360 Peripheral Orbital Atherectomy System DiamondBack 360 Peripheral Orbital Atherectomy System, Exchangeable

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device