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510(k) Data Aggregation

    K Number
    K050311
    Device Name
    ATRIUM MEDICAL CORPORATION C-QUR MESH
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2006-03-31

    (416 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATRIUM MEDICAL CORPORATION C-QUR MESH

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

    Atrium C-QUR™ Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for the Atrium C-Qur Mesh. This document only states that the device has been found substantially equivalent to a predicate device for certain indications for use.

    It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

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

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