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510(k) Data Aggregation

    K Number
    K162184
    Device Name
    Edwards eSheath Introducer Set
    Manufacturer
    Edward Lifesciences
    Date Cleared
    2016-09-02

    (29 days)

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

    Edward Lifesciences

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Edwards eSheath Introducer Set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Transcatheter Heart Valve.
    Device Description
    The Edwards eSheath Introducer Set consists of a sheath and two dilators packaged together, and one loader packaged with the Commander delivery system. The Edwards eSheath Introducer Set is available in two sizes: model 914ES (14F inner diameter) and model 916ES (16F inner diameter). The 14F eSheath introducer set is used to facilitate introduction of the 20mm, 23mm and 26mm SAPIEN 3 THV and Commander Delivery System into the vasculature, and the 16F eSheath introducer set is used to facilitate introduction of the 29mm SAPIEN 3 THV and Commander Delivery System into the vasculature. The sheath shaft is comprised of 2 layers of material (HDPE/TecoFlex coextruded outer layer and PTFE liner). The outer and inner layer are folded, creating a seam which allows the distal region of the sheath to temporarily expand in diameter when a device is inserted. A tapered strain relief at the proximal end of the sheath shaft helps provide hemostasis when the sheath is inserted. The sheath shaft exterior includes a hydrophilic coating to facilitate introduction into the target vessel. The distal end of the shaft features a radiopaque marker, and the shaft mates proximally with a housing that contains three valves (seals) to provide hemostasis, an extension tube for flushing, and suture holes on the exterior. Two dilators are provided to aid in the introduction of the sheath into the target vessel, and can also be used for dilation of the vessel prior to sheath insertion. The dilators are radiopaque and feature a tapered tip and guidewire lumen. The loader features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.
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