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

    CARDIOVASCULAR SET UP

    K Number: K850341 · Decision Feb 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    CARDIOVASCULAR SET UP
    K Number
    K850341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Marwood Medical, Inc.
    Date Received
    January 28, 1985
    Decision Date
    February 25, 1985
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Marwood Medical, Inc.

    K Number Device Name
    K850340 EYE PROCEDURE PACK
    K850338 EMERGENCY ROOM PACK
    K850339 SPECIAL PROCEDURES PACK
    K850337 CARDIAC CATHETERIZATION PACK
    K840620 TPN/CVP DRESSING CHANGE KIT
    K840619 I.V. START KIT