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510(k) Data Aggregation

    K Number
    K972511
    Device Name
    AMPLATZ GOOSE NECK SNARE KIT/ CATHETER
    Manufacturer
    MICROVENA CORP.
    Date Cleared
    1998-03-06

    (246 days)

    Product Code
    DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K901502
    Why did this record match?
    Device Name :

    AMPLATZ GOOSE NECK SNARE KIT/ CATHETER

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

    The Amplatz Goose Neck Snare is a Class II device intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.

    Device Description

    The Amplatz Goose Neck Snare consists of a braided nitinol loop attached to a solid core nitinol guidewire. The plane of the loop is perpendicular to the host wire. The loop is covered with a gold-plated tungsten coil to enhance radiopaque. The shaft of the snare consists of a solid continuous Nitinol core wire shaft. The loop snare is delivered in a multi-purpose catheter. The catheter has a radiopaque marker band at its distal tip. The package configuration consists of a compact spiral configuration, using hoops to contain the snare and catheter. These spiral hoops are then double pouched in Tyvek/mylar pouches.

    AI/ML Overview

    The provided 510(k) summary for the Amplatz Goose Neck Snare (K972511) does not contain a detailed study report that includes acceptance criteria and performance data in the format requested.

    The document states: "The Amplatz Goose Neck Snare received clearance for market based on functional and safety testing detailed in the original premarket notification K901502." This means the detailed study information regarding acceptance criteria and performance would be found in the K901502 submission, which is not provided in this document.

    Therefore, I cannot populate the requested table and answer the study-specific questions based on the information given. The current document is a summary of the 510(k) application for a new version of the device, referencing the original clearance for the testing.

    The document focuses on establishing substantial equivalence to a predicate device (MICROVENA Amplatz Goose Neck Snare, K901502) based on design and intended use, rather than presenting new performance data from a specific study for K972511.

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