BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    ARCOLITH 4000

    K Number: K791165 · Decision Jul 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    460
    Applicant Total
    21
    Review Days
    15

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    Basic Information

    Device Name
    ARCOLITH 4000
    K Number
    K791165
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Arco Medical Products Co.
    Date Received
    June 25, 1979
    Decision Date
    July 10, 1979
    Product Code
    DXY
    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
    DXY Implantable Pacemaker Pulse-Generator

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    Other Clearances by Arco Medical Products Co.

    K Number Device Name
    K802588 MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.
    K801806 EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE
    K800837 PROGRAMMABLE BIPOLAR CARDIAC GENERATOR
    K801241 UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.
    K800838 ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.
    K800326 ARCOLITH 3021-CARDIAC PULSE GENERATOR
    K792216 ARCOLITH 2100-CARDIAC PULSE GENERATOR
    K792299 ARCOLITH 3020-CARDIAC PULSE GENERATOR
    K791715 ARCOLITH 2000
    K791147 ARCO PROGAMMABLE PACEMAKER SYSTEM
    Search all 21 clearances from Arco Medical Products Co. →