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510(k) Data Aggregation

    K Number
    K013913
    Device Name
    PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
    Manufacturer
    MEDTRONIC PERCUSURGE, INC.
    Date Cleared
    2002-11-15

    (353 days)

    Product Code
    NFA
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K003992
    Why did this record match?
    Device Name :

    PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

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

    The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:

    • Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
    • To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
    • The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
    • The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
    • The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
    Device Description

    The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter. The GuardWire Plus System is a sterile, single-use disposable device.

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System primarily establishes substantial equivalence to a predicate device rather than defining new, specific acceptance criteria for performance metrics in a standalone study. Therefore, the "acceptance criteria" are implicitly met by demonstrating comparable safety and efficacy to the predicate device.

    Acceptance Criteria (Implied by Substantial Equivalence)Reported Device Performance (from SAFER Study (K003992))
    Safety and Efficacy in Coronary Saphenous Vein Bypass Grafts (2.5-5.0mm) for:
    • Containment and aspiration of embolic material
    • Subselective infusion/delivery of agents | **Reference Vessels Diameter
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