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

    Millipede 088 Access Catheter

    K Number: K231802 · Decision Sep 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    9
    Review Days
    91

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    Basic Information

    Device Name
    Millipede 088 Access Catheter
    K Number
    K231802
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perfuze, Ltd.
    Date Received
    June 20, 2023
    Decision Date
    September 19, 2023
    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

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    Other Clearances by Perfuze, Ltd.

    K Number Device Name
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    K240711 Zipline Access Catheter
    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
    K214048 Millipede 088 Access Catheter