BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

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

    K Number: K191114 · Decision Aug 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
    K Number
    K191114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1252
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avenu Medical
    Date Received
    April 26, 2019
    Decision Date
    August 9, 2019
    Product Code
    PQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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