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510(k) Data Aggregation

    K Number
    K130293
    Device Name
    ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
    Manufacturer
    COOK, INC.
    Date Cleared
    2013-05-31

    (114 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K073378
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    Device Description

    The Advance 18LP Low Profile PTA Balloon Dilatation Catheter is an over-the-wire catheter. The 4 Fr balloon catheter will be compatible with a 0.018 inch wire guide. The balloon catheter will be supplied sterile, intended for one-time use.

    AI/ML Overview

    The provided document describes the acceptance criteria and performance study for a medical device, specifically the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter, not an AI or software device. Therefore, many of the typical criteria for evaluating AI/software performance, such as MRMC studies, training set details, or expert ground truth adjudication, are not applicable here.

    The study focuses on the physical and functional performance of the balloon catheter to demonstrate its substantial equivalence to a predicate device for a 510(k) submission.

    Here's an analysis of the provided information, framed within the requested categories where applicable, with an emphasis on what is present and what is not for a medical device (as opposed to an AI/software device):

    Acceptance Criteria and Device Performance for the Advance® 18LP Low Profile PTA Balloon Dilatation Catheter

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    1. Balloon Minimum Burst Strength (Balloon must burst at or above minimum rated burst pressure, with linear tears.)Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. The predetermined acceptance criteria were met.
    2. Balloon Compliance (Balloon must meet labeled diameter within tolerance at nominal pressure under simulated body temperature.)Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. The predetermined acceptance criteria were met.
    3. Balloon Profile (Catheter shaft, bonds, and folded balloon must be compatible with 4, 5, 6, or 7 Fr sheath profiles (
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