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510(k) Data Aggregation

    K Number
    K022620
    Device Name
    SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Date Cleared
    2002-10-11

    (65 days)

    Product Code
    FKA
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    FKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Percutaneous insertion kit designed to provide physicians with a dual wire technique for use with Spire Biomedical, Inc.'s Pourchez XpressO™ and Pourchez RetrO™ catheters only.
    Device Description
    The "SafeTrac Dual Wire Insertion Kit" provides an alternative method for chronic hemodialysis catheter placement by using an over the wire technique dilating and inserting either the Pourchez RetrO and XpressO catheters over a guidewire percutaneously. The introducers consist of a plastic hub attached to a plastic cannula. The distal end of the cannula is thermally tapered to assist dilation. The hub proximal end has a female luer lock configuration. An optional hub collar may be used to attach the dilator to the catheter. The kits come with two quidewires, two 5F dilators, a 6F, 14F and 16F sheath/dilators in five different lengths. Each kit consists are to be supplied sterile and for single use only. The kits are to be sold in boxes of five.
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