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510(k) Data Aggregation

    K Number
    K983758

    Validate with FDA (Live)

    Device Name
    YASARGIL TITANIUM ANEURYSM CLIPS
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1998-12-18

    (53 days)

    Product Code
    HCH
    Regulation Number
    882.5200
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K955064,K760771,K782040
    Predicate For
    K013136,K131500,K173271,K991959
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Yasargil Titanium Aneurysm Clips presented in this submission are intended for occlusion of cerebral aneurysms in either a temporary or permanent manner. They are applied by Aesculap clip appliers with titanium alloy jaws.

    Device Description

    These titanium alloy aneurysm clips will be available as temporary or permanent devices.

    AI/ML Overview

    The provided text is a 510(k) summary for Yasargil Titanium Aneurysm Clips. This document asserts substantial equivalence to previously marketed devices and describes the product's intended use and technological characteristics. However, it does not contain any information regarding performance studies, acceptance criteria, or specific metrics typically associated with device performance evaluation.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence rather than detailed performance study results.

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