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510(k) Data Aggregation

    K Number
    K991194
    Device Name
    MODIFICATION TO ULTRA-SELECT GUIDEWIRE
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1999-05-05

    (27 days)

    Product Code
    DQX,DOX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K922060
    Why did this record match?
    Device Name :

    MODIFICATION TO ULTRA-SELECT GUIDEWIRE

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

    The 0.025" HyTek guidewire is indicated for use in the peripheral vasculature. The 0.014". 0.016", and 0.018" HyTek Guidewires are indicated for use in the peripheral and coronary vasculature.

    Device Description

    The MICROVENA HyTek Guidewire is designed to fit inside a catheter, for directing the catheter through a blood vessel.

    The main body of the guidewire is constructed of Nitinol. The distal tip is a helical coiled wire wound around the inner core. The guidewire is coated with a hydrophilic coating to facilitate smoother passage.

    The HyTek Guidewire is available in diameters of .014" to .025, and in lengths from 80 cm to 300 cm.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI-powered medical device. Instead, it is a 510(k) summary for a traditional medical device (guidewire) seeking substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested table or answer the questions related to AI device performance evaluation as the provided text pertains to a conventional medical device submission. The focus of this document is on the physical characteristics and intended use of the HyTek Guidewire and its comparability to an existing device, not on the performance of a software algorithm.

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