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510(k) Data Aggregation

    K Number
    K033989
    Device Name
    MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
    Manufacturer
    MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT
    Date Cleared
    2004-01-22

    (30 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The deflectable catheter system is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart, and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.
    Device Description
    The Medtronic SelectSite Model C304 Deflectable Catheter System is designed to facilitate the introduction of transvenous devices within the chambers and coronary vasculature of the heart and the introduction of leads in the left heart via the coronary sinus. The Model C304-S59 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 30 cm. The Model C304-L69 deflectable catheter has a single lumen for passage of transvenous devices with a maximum outer diameter of 5.6 French (1.9 mm) and a usable length of 40 cm. The deflectable catheter features a deflecting distal section controlled by the deflectable catheter handle for placement of transvenous devices within the chambers of the heart and for coronary sinus cannulation. The body of the deflectable catheter is radiopaque for visibility on fluoroscopy.
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