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

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

    K Number: K200634 · Decision Apr 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
    K Number
    K200634
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3535
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arrow International Inc.
    Date Received
    March 10, 2020
    Decision Date
    April 9, 2020
    Product Code
    DSP
    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
    DSP System, Balloon, Intra-Aortic And Control

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