Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213602
    Manufacturer
    Date Cleared
    2022-01-14

    (60 days)

    Product Code
    Regulation Number
    876.5630
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.

    Device Description

    The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.

    The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.

    The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.

    AI/ML Overview

    This is not an AI/ML device, therefore, the requested information is not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1