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

    PLATINUM SERIES EP DIAGNOSTIC CATHETERS

    K Number: K953185 · Decision Apr 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    5
    Review Days
    280

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    Basic Information

    Device Name
    PLATINUM SERIES EP DIAGNOSTIC CATHETERS
    K Number
    K953185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Cardiorhythm
    Date Received
    July 10, 1995
    Decision Date
    April 15, 1996
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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