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510(k) Data Aggregation

    K Number
    K203767
    Device Name
    Pristine Long-Term Hemodialysis Catheter
    Manufacturer
    C B Bard, Inc
    Date Cleared
    2021-04-02

    (100 days)

    Product Code
    MSD
    Regulation Number
    876.5540
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    Applicant Name (Manufacturer) :

    C B Bard, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pristine™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, apheresis and infusion. Access is attained via the internal jugular vein, or femoral vein. Catheters longer than 40 cm implant length are indicated for femoral vein insertion. Catheters may be inserted percutaneously.
    Device Description
    The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis, apheresis, and infusion. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter bifurcation and suture wings (hub). The distal end of the catheter hub is connected to the dual lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical split tip. The design of the catheter's distal tip includes a split, symmetric Y-Tip™ with notches and without side-holes or slots. The symmetric Y-Tip™ design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Long-Term Hemodialysis Catheter is provided as a sterile, single use device, and is sterilized using a validated ethylene oxide process. The dialysis catheters are offered in various implant lengths, varying from 19 cm to 55 cm as depicted below.
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