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

    K-STIK DEFIBRILLATION PADS

    K Number: K863899 · Decision Nov 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    26
    Review Days
    36

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    Basic Information

    Device Name
    K-STIK DEFIBRILLATION PADS
    K Number
    K863899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Katecho, Inc.
    Date Received
    October 7, 1986
    Decision Date
    November 12, 1986
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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    Other Clearances by Katecho, Inc.

    K Number Device Name
    K012404 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
    K010543 KM-30 TENS ELECTRODE
    K003228 K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
    K002806 K-DEFIB/PACE, MODEL KDP-60A
    K000870 KM-10 TENS ELECTRODE
    K993745 K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
    K991007 K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
    K981737 K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
    K954504 K-DEFIB/PACE PEDIATRIC ELECTRODE
    K934692 K-DEFIB/PACE PEDIATRIC ELECTRODE
    Search all 26 clearances from Katecho, Inc. →