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

    CARDIO METRIC CUSTOM PERFUSION TUBING

    K Number: K841959 · Decision Oct 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    20
    Applicant Total
    10
    Review Days
    158

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    Basic Information

    Device Name
    CARDIO METRIC CUSTOM PERFUSION TUBING
    K Number
    K841959
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sterile Design, Inc.
    Date Received
    May 14, 1984
    Decision Date
    October 19, 1984
    Product Code
    DWE
    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
    DWE Tubing, Pump, Cardiopulmonary Bypass

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    Other Clearances by Sterile Design, Inc.

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    K841958 CARDIO METRICS CARDIOTOMY RESERVOIR
    K842351 STERILE DESIGN-CUSTOM STERILE IV KIT
    K834239 SDI C-FLEX STERILE LIGHT HANDLE
    K834237 GRADUATED GUIDE WIRE BOWL 8
    K813437 PAN SET
    K791738 CUSTOM DRESSING CHANGE TRAYS