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510(k) Data Aggregation

    K Number
    K990221
    Device Name
    INTRACOIL PERIPHERAL STENT
    Manufacturer
    INTRATHERAPEUTICS, INC.
    Date Cleared
    1999-06-02

    (131 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K963241,K982184
    Why did this record match?
    Device Name :

    INTRACOIL PERIPHERAL STENT

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

    The IntraCoil® Peripheral Stent is indicated for use in the treatment of bronchial strictures produced by malignant neoplasms.

    Device Description

    The IntraCoil® Stent is a self-expanding nickel-titanium (Nitinol) coil premounted on a delivery catheter. Upon deployment the stent expands to conform to the bronchial lumen surface. The stent's purpose is to increase or maintain the inner lumenal diameter of the bronchial passage.

    AI/ML Overview

    I am sorry, but there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) premarket notification summary for a medical device (IntraCoil® Peripheral Stent), which focuses on establishing substantial equivalence to previously cleared devices rather than presenting the results of a primary clinical study with acceptance criteria.

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