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510(k) Data Aggregation

    K Number
    K993149
    Device Name
    PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
    Manufacturer
    MEDIONICS INTERNATIONAL, INC.
    Date Cleared
    2000-04-28

    (220 days)

    Product Code
    FJS
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERITONEAL DIALYSIS CATHETERS AND ADAPTERS

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

    Peritoneal Dialysis Catheters and Adapters are access devices used for providing peritoneal dialysis treatment for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in a consistent manner, without requiring extraordinary effort or causing discomfort.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Peritoneal Dialysis Catheters and Adapters (K993149). It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria, device performance data, details of a study proving the device meets acceptance criteria, sample sizes, ground truth information, expert qualifications, or details about comparative effectiveness studies.

    Therefore, I cannot fulfill your request as the provided text lacks the necessary information.

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