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510(k) Data Aggregation

    K Number
    K021990
    Device Name
    GALT MEDICAL GUIDEWIRE
    Manufacturer
    GALT MEDICAL CORP.
    Date Cleared
    2002-07-18

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K982559
    Predicate For
    K031916,K033542,K151234
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

    Device Description

    The materials of construction stainless steel, nitinol, platinum are consistent with guidewires presently in commercial distribution. The wires are available straight, or with "J" end. The wires range from .014" diameter through .025" diameter and lengths from 20cm. to 360 cm. The wires may also be PTFE coated.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (guidewire) and does not describe an AI/ML device or a study involving acceptance criteria for such a device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies, as these concepts are not applicable to the provided document.

    The document discusses the substantial equivalence of Galt Medical's Vascular Guidewires (Mandrel Type) to previously marketed guidewires (predicate devices) based on non-clinical tests like tensile strength and torqueability. It's a regulatory submission for a traditional medical device, not a software or AI/ML product.

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