BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JETi Hydrodynamic Thrombectomy System

    Reg #: 3006604866 · FEI: 3006604866 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Abbott West Distribution Center
    Registration Number
    3006604866
    FEI Number
    3006604866
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    42301 Zevo Drive
    City
    Temecula
    State
    CA
    ZIP
    92590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232458

    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
    Aspiration Thrombectomy Catheter QEZ
    Stand, Infusion FOX
    Bottle, Collection, Vacuum KDQ

    Proprietary Names

    JETi Hydrodynamic Thrombectomy System

    Establishment Types

    Manufacture Medical Device