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510(k) Data Aggregation

    K Number
    K123334
    Device Name
    REPROCESSED STEERABLE INTRODUCER
    Date Cleared
    2013-01-24

    (90 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER SUSTAINABILITY SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reprocessed Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The Reprocessed Steerable Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is filtered with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise less than or equal to 90 degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.
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    K Number
    K121913
    Device Name
    REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
    Date Cleared
    2012-12-20

    (171 days)

    Product Code
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRYKER SUSTAINABILITY SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
    Device Description
    The Reprocessed Ultra IntraCardiac Echo Diagnostic Ultrasound Catheter is a 9F (3mm) diameter and 9 MHz frequency IntraCardiac Echocardiography Catheter which is 110cm in lenath. The Ultra IntraCardiac Echo Catheter is constructed with an inner core and proximal connector. The catheter has a distal imaging window and an inserted rotatable imaging core with a distal ultrasound transducer. The 9F (3mm)/9MHz Ultra IntraCardiac Echo Catheter can be used with the ClearView Ultra™ DSP system only after implementation of version 4.22 software or higher, or the Galaxy™ system. Ultra IntraCardiac Echo Catheters rely on the rotational fidelity of the internal transducer and driveshaft assembly to accurately coincide with the position sensing electronics located in the Motordrive Unit (MDU). This arrangement is necessary in order to reduce the overall diameter of the catheter and to ensure that image information is displayed correctly on the screen.
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