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

    ANGIOUROGRAPHY KIT

    K Number: K822159 · Decision Nov 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    92
    Review Days
    103

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    Basic Information

    Device Name
    ANGIOUROGRAPHY KIT
    K Number
    K822159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    July 23, 1982
    Decision Date
    November 3, 1982
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Mallinckrodt Critical Care

    K Number Device Name
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    K874514 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
    K874568 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
    K874404 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
    K873461 LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
    K873833 THERMOCOUPLE ADAPTER
    K873004 GUIDING CATHETER
    K871204 CUFFED TRACHEAL TUBE (MULTIPLE)
    K862666 UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
    Search all 92 clearances from Mallinckrodt Critical Care →