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510(k) Data Aggregation

    K Number
    K131144
    Device Name
    AMECO SHEATH INTRODUCER
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2013-08-15

    (114 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMECO SHEATH INTRODUCER

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

    The Percutaneous sheath introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth for a medical device. The document is an FDA 510(k) clearance letter for an "Ameco Sheath Introducer" and primarily addresses its regulatory status and substantial equivalence to predicate devices. It outlines general controls, regulations, and contact information, but it does not include any performance study data or detailed information that would allow me to answer your questions.

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