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

    FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile

    K Number: K170029 · Decision Dec 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    3
    Review Days
    345

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    Basic Information

    Device Name
    FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
    K Number
    K170029
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biophysics Corporation
    Date Received
    January 4, 2017
    Decision Date
    December 15, 2017
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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    Other Clearances by International Biophysics Corporation

    K Number Device Name
    K193663 FloPump 57mL Centrifugal Pump
    K122480 INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST