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

    Ellipsys Vascular Access System

    K Number: DEN170004 · Decision Jun 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    3
    Review Days
    528

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    Basic Information

    Device Name
    Ellipsys Vascular Access System
    K Number
    DEN170004
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.1252
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Avenu Medical, Inc.
    Date Received
    January 10, 2017
    Decision Date
    June 22, 2018
    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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    Other Clearances by Avenu Medical, Inc.

    K Number Device Name
    K183615 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
    K181725 Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)