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    FDA Registration Active 🇺🇸 United States

    Avenu7784 (TM) - Ellipsys Vascular Access System

    Reg #: 2030624 · FEI: 3000206435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2030624
    FEI Number
    3000206435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43425 Business Park Dr
    City
    Temecula
    State
    CA
    ZIP
    92590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191114

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

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

    Proprietary Names

    Avenu7784 (TM) - Ellipsys Vascular Access System Medtronic2686 (MN) - Ellipsys® Vascular Access System (Catheter)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)