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

    AC3 Series Intra-Aortic Balloon Pump (IABP)

    K Number: K192238 · Decision Nov 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    161
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    AC3 Series Intra-Aortic Balloon Pump (IABP)
    K Number
    K192238
    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, Teleflex
    Date Received
    August 19, 2019
    Decision Date
    November 12, 2019
    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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