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510(k) Data Aggregation

    K Number
    K051096
    Device Name
    APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Date Cleared
    2005-05-17

    (18 days)

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

    ST. JUDE MEDICAL, DAIG DIVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apeel CS Plus Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.
    Device Description
    The Apeel™ CS Plus Catheter Delivery System includes a Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port with 3-way Stopcock, Guidewire, Syringe, Needle, and 2 Valve Bypass Tools. The introducer kits are provided sterile, and are intended for single-use only.
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    K Number
    K042623
    Device Name
    AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Date Cleared
    2005-01-27

    (122 days)

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

    ST. JUDE MEDICAL, DAIG DIVISION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The St. Jude Medical (SJM) Agilis™ Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
    Device Description
    The Agilis™ Steerable Catheter 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 fitted 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. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.
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