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510(k) Data Aggregation

    K Number
    K110793
    Device Name
    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2011-12-16

    (269 days)

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

    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

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

    Indicated for acute hemodialysis and apheresis. They may be inserted perculaneously and are idealy placed in the internal jugularyon and apricless. They may be inserted percuraneously and an the internal jugular is the preferred site the preferred site.

    Device Description

    "Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for "Amecath" and "Amecath UniQath Soft" short term dual hemodialysis catheterization kits. It includes details about the device's indications for use and classification.

    However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC or standalone).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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