BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Zipline Access Catheter

    K Number: K240711 · Decision Oct 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    76
    Applicant Total
    7
    Review Days
    216

    Basic Information

    Device Name
    Zipline Access Catheter
    K Number
    K240711
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perfuze Ltd.
    Date Received
    March 15, 2024
    Decision Date
    October 17, 2024
    Product Code
    QJP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QJP Catheter, Percutaneous, Neurovasculature

    Similar 510(k) Clearances

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

    FUBUKI XF-R Neurovascular Long Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Branchor X Balloon Guide Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    93 NeuFlex Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PATH BGC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXS Lift Intracranial Base Catheter

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

    Other Clearances by Perfuze Ltd.

    K Number Device Name
    K250012 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    K242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    K233648 Millipede 088 Access Catheter
    K232524 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    K231802 Millipede 088 Access Catheter
    K214048 Millipede 088 Access Catheter