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510(k) Data Aggregation

    K Number
    K182443
    Device Name
    Pristine Hemodialysis Catheter
    Manufacturer
    Pristine Access Technologies Ltd.
    Date Cleared
    2019-05-31

    (266 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pristine Access Technologies Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pristine™ Hemodialysis Catheter is indicated for acute and chronic hemodialysis, apheresis and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40cm implant length are indicated for femoral placement.
    Device Description
    Pristine™ Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables a long-term vascular access for hemodialysis and apheresis. 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 junction 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 tip with notches and without side-holes nor slots. The symmetric tip design allows a spatial separation between the distal ends of the two lumens. The Pristine™ Hemodialysis Catheter is packed along with a Tunneler and two sealing caps in a vented blister tray and lid, sealed within a Tyvek pouch. The packed catheter and accessories set is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.
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