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510(k) Data Aggregation

    K Number
    K981642
    Device Name
    STABLEMAPR STEERABLE INTRACARDIAC CATHETERS
    Manufacturer
    MEDTRONIC CARDIORHYTHM
    Date Cleared
    1998-08-05

    (89 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIORHYTHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic CardioRhythm StableMapr Catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
    Device Description
    The StableMapr Series of EP Diagnostic Catheters are used to record electrical activity from within the heart and its vasculature and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions. The StableMapr Catheters are closed-lumen diagnostic electrophysiology catheters with a variable number of platinum allov recording/stimulating electrodes fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The StableMapr Catheters include addition mapping electrodes and a preformed distal tip section, as well as other minor modifications for improved manufacturability. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrode to the electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curvature of the catheter tip. All models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
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    K Number
    K964272
    Device Name
    PERFORMR SERIES EP DIAGNOSTIC CATHETERS
    Manufacturer
    MEDTRONIC CARDIORHYTHM
    Date Cleared
    1997-01-23

    (90 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIORHYTHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulatorrecorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
    Device Description
    The Performr Series Catheter is a closed-lumen diagnostic electrophysiology catheter with a variable number of platinum alloy recording/stimulating electrodes (2-11) fixed around the catheter shaft. The most distal electrode is located at the catheter tip. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each electrical connector at the proximal end of the catheter. The outside diameter of the catheter is 5 to 7 French and the usable length ranges from 60 to 125 cm. A manipulator handle at the proximal end of the catheter permits the physician to vary the angle of curve of the catheter tips. Some models have controls in the handle to vary the radius of curvature, and the distal end of some models may be laterally deflected.
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    K Number
    K953185
    Device Name
    PLATINUM SERIES EP DIAGNOSTIC CATHETERS
    Manufacturer
    MEDTRONIC CARDIORHYTHM
    Date Cleared
    1996-04-15

    (280 days)

    Product Code
    DRF
    Regulation Number
    870.1220
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC CARDIORHYTHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and coronary vessels and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
    Device Description
    The Platinum Series EP Diagnostic Catheter is an electrophysiology catheter with a range of two to ten platinum recording/stimulating electrodes arranged on its distal end. The distal band electrode is approximately .050" from the spherically molded Pebax tip. The distal band electrode serves as the tip electrode. The electrode bands are welded to electrical wires incorporated inside the shaft of the catheter that run from each platinum electrode to the electrical connector in the proximal end. The outside diameter of the catheter is 5 to 6 French and the usable length ranges from 60 to 125 cm.
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