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

    PLASTIC TUBING ADAPTERS 5-IN-1-

    K Number: K800880 · Decision May 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    PLASTIC TUBING ADAPTERS 5-IN-1-
    K Number
    K800880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Harvard Laboratories
    Date Received
    April 17, 1980
    Decision Date
    May 14, 1980
    Product Code
    DTL
    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
    DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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    Other Clearances by Harvard Laboratories

    K Number Device Name
    K822765 SIGMOIDOSCOPE, FLEXIBLE
    K810573 TUBE FEEDING SET
    K810574 SUCTION COLLECTION BOTTLE, DISPOSABLE
    K800879 CLEAR PLASTIC CONNECTING TUBES
    K800877 ANESTHESIA EXTENSION TUBES
    K800878 SECONDARY I.V. TUBING SETS
    K800881 DISPOSABLE BERMAN AIRWAYS