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510(k) Data Aggregation

    K Number
    K110794
    Device Name
    AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2011-12-21

    (274 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS

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

    Indicated to permit short-term (

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Ameco Medical Industries for their "Amecath CVC" and "Amecath Pressure CVC" short-term single and multi-lumen catheterization kits.

    This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria for a device's performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, classification, and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

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