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510(k) Data Aggregation

    K Number
    K983039
    Device Name
    EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
    Manufacturer
    Date Cleared
    1999-05-07

    (249 days)

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

    SCHNEIDER/NAMIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath.
    Device Description
    The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer sheath and a dilator. The Emcee Infusion Introducer Sheath Set may also contain a guidewire. Design features have been added to the Emcee Introducer Set (K980504) to enhance the facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. These design features include the addition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes.
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    K Number
    K980504
    Device Name
    EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
    Manufacturer
    Date Cleared
    1998-08-07

    (179 days)

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

    SCHNEIDER/NAMIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).
    Device Description
    The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator. The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration. Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed. The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences. The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo. Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.
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