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

    PARTNER SEVEN DISP. BUBBLE OXYGENATOR

    K Number: K800555 · Decision Apr 4, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    PARTNER SEVEN DISP. BUBBLE OXYGENATOR
    K Number
    K800555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardiovascular Research, Inc.
    Date Received
    March 12, 1980
    Decision Date
    April 4, 1980
    Product Code
    DTZ
    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
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by Cardiovascular Research, Inc.

    K Number Device Name
    K843118 CANNULA INTRODUCER