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510(k) Data Aggregation

    K Number
    K990470
    Device Name
    JMS A. V. FISTULA NEEDLE SET
    Manufacturer
    JMS CO., LTD.
    Date Cleared
    1999-08-30

    (195 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JMS A. V. FISTULA NEEDLE SET

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

    Use for temporary cannulation for vascular access for extracorporeal blood treatment. This device is intended to single use only and is for temporary catheterization less than 30 days. Regarding to pre-attached Anti-stick device, use for prevention of needlestick injury at the time of needle withdrawal after usage.

    Device Description

    Needle, Fistula

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "JMS A.V. Fistula Needle Set." These documents do not contain any information regarding acceptance criteria or a study proving that a device meets such criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily based on design, materials, and intended use, rather than detailed performance study data against specific acceptance criteria as you would find for a novel device or a device requiring clinical trials.

    Therefore, I cannot provide the requested information based on the input documents.

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