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

    ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,

    K Number: K112587 · Decision Dec 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    20
    Applicant Total
    43
    Review Days
    104

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    Basic Information

    Device Name
    ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
    K Number
    K112587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Terumo Cardiovascular Systems Corp.
    Date Received
    September 6, 2011
    Decision Date
    December 19, 2011
    Product Code
    DWB
    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
    DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

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