BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ellipsys Vascular Access System (Ellipsys System), Power Controller, Catheter, Crossing Needle

    Reg #: 3014251914 · FEI: 3014251914 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AVENU MEDICAL (FORMERLY CAYMUS MEDICAL)
    Registration Number
    3014251914
    FEI Number
    3014251914
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27123 CALLE ARROYO # 2101
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191114

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access PQK

    Proprietary Names

    Ellipsys Vascular Access System (Ellipsys System), Power Controller, Catheter, Crossing Needle

    Establishment Types

    Manufacture Medical Device