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

    Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)

    K Number: K181725 · Decision Oct 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    6
    Applicant Total
    3
    Review Days
    98

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
    K Number
    K181725
    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, Inc.
    Date Received
    June 29, 2018
    Decision Date
    October 5, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PQK), ordered by most recent decision date.

    WavelinQ Plus EndoAVF System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WavelinQ 4F EndoAVF System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ellipsys Vascular Access System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    everlinQ endoAVF System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    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
    DEN170004 Ellipsys Vascular Access System