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

    MARINR SERIES EP DIAGNOSTIC CATHETERS

    K Number: K931794 · Decision Jun 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    5
    Review Days
    420

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    Basic Information

    Device Name
    MARINR SERIES EP DIAGNOSTIC CATHETERS
    K Number
    K931794
    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
    April 12, 1993
    Decision Date
    June 6, 1994
    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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    Other Clearances by Medtronic Cardiorhythm

    K Number Device Name
    K981642 STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
    K964272 PERFORMR SERIES EP DIAGNOSTIC CATHETERS
    K953185 PLATINUM SERIES EP DIAGNOSTIC CATHETERS
    K951347 MARINR SERIES EP DIAGNOSTI CATHETERS