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510(k) Data Aggregation

    K Number
    K102588
    Device Name
    ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
    Manufacturer
    MEDTRONIC ABLATION FRONTIERS, LLC
    Date Cleared
    2011-03-18

    (190 days)

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

    MEDTRONIC ABLATION FRONTIERS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Catheter is designed to obtain electrograms in the atrial regions of the heart.
    Device Description
    The Achieve™ diagnostic mapping catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve catheter is a circular loop with eight evenly spaced electrodes to map electrical conduction within the atrium. The Achieve catheter should only be used with the corresponding electrical cable for Achieve. The Achieve catheter is available with two distal loop diameter sizes described in the following table: | Model | Loop Diameter | |------------|---------------| | 990063-015 | 15 mm | | 990063-020 | 20 mm | The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment.
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