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510(k) Data Aggregation

    K Number
    K113300
    Device Name
    ATB ADVANCE PTA DILATATION CATHETER
    Manufacturer
    COOK, INC.
    Date Cleared
    2011-12-09

    (30 days)

    Product Code
    LIT,DOY
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K033875,K052036,K063252
    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. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents.

    Device Description

    The ATB Advance® PTA Dilatation Catheter is an over-the-wire catheter indicated 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. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents. The 6 Fr balloon catheter will be compatible with a 0.035 inch wire guide and an 8 Fr sheath. It will be supplied sterile, intended for one-time use.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the ATB Advance® PTA Dilatation Catheter:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Balloon Minimum Burst Strength: Burst at or above the minimum rated burst pressure.Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. Predetermined acceptance criteria met.
    Balloon Compliance: Meet labeled diameter within tolerance at the nominal pressure under simulated body temperature conditions.Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. Predetermined acceptance criteria met.
    Balloon Profile: Compatible with an 8 Fr sheath (
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