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510(k) Data Aggregation

    K Number
    K143561
    Device Name
    ELM PTA Balloon Dilatation Catheter
    Date Cleared
    2015-05-19

    (154 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    O'CONNELL REGULATORY CONSULTANTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ELM Extension PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
    Device Description
    The Creagh Medical ELM Balloon Dilatation Catheter is a coaxial catheter with a semi compliant balloon near the distal tip. It is an Over-the-Wire (OTW) PTA device with shaft lengths of 40cm & 75cm. The ELM PTA Balloon Dilatation Catheter is compatible with a 0.035" guide wire. The balloon has two radiopaque markers at either end of the balloon body that aid in the placement of the balloon within the stenosis. These two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement. The marker bands also indicate the nominal length of the balloon. The catheter tip is designed to ease entry into the peripheral arteries and to facilitate the crossing of tight stenosis. The clearance between the inner and outer catheter shaft acts as the passage for the inflation medium for balloon expansion. The proximal end of the catheter has a bifurcated manifold and strain relief that allows for the use of the 0.035" guidewire and the attachment of a balloon inflation device via a standard luer connector. The inflation device is used to inflate and deflate the balloon with a contrast medium. The ELM PTA Balloon Dilatation Catheter is to be provided sterile (via ethylene oxide) and is intended for single use only. The catheter is designed so that a specific balloon diameter can be reached depending on the Balloon size and defined pressure. A compliance chart is provided on the product label which provides the diameter of balloons at given pressures. Each product is packaged with a balloon protector which is positioned over the balloon for its protection prior to use. A re-wrap tool is also provided on the catheter shaft. The modified ELM 0.035" PTA Balloon Dilatation Catheter, hereafter referred to as ELM Extension, introduces 3 additional product codes with reduced Rated Burst Pressure as detailed below in Table 1.
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