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

    SARNS PULSATILE PUMP

    K Number: K820729 · Decision Nov 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    20
    Applicant Total
    76
    Review Days
    229

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    Basic Information

    Device Name
    SARNS PULSATILE PUMP
    K Number
    K820729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    March 17, 1982
    Decision Date
    November 1, 1982
    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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