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    K Number
    K014140
    Device Name
    RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
    Manufacturer
    SUNDER BIOMEDICAL TECH. CO., LTD.
    Date Cleared
    2002-11-18

    (336 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

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

    The RENAX (SUNDER) HEMODIALYSIS BLOOD TUBING SET (model: SD-K01, SD-G01) is intended to serve as a conduit through which blood is taken from the patient, delivered to the hemodialyzer, and returned to the patient during hemodialysis therapy. The device is intended to be used for patients suffering from renal disease only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a hemodialysis blood tubing set. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

    The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, which means it is considered as safe and effective as existing devices on the market. However, it does not provide details of any specific performance studies or acceptance criteria beyond stating its intended use.

    Therefore, I cannot provide the requested information based on the provided text.

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