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510(k) Data Aggregation

    K Number
    K972777
    Device Name
    TEMPORARY OCCLUSION BALLOON SYSTEM
    Manufacturer
    PERCUSURGE, INC.
    Date Cleared
    1998-03-11

    (229 days)

    Product Code
    MJN,DAT
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEMPORARY OCCLUSION BALLOON SYSTEM

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

    The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion. The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).

    Device Description

    PercuSurge Temporary Occlusion Balloon (TOB) System

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the PercuSurge Temporary Occlusion Balloon (TOB) System. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter explicitly states: "The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS)." and "The safety and effectiveness of the PercuSurge Temporary Occlusion Balloon (TOB) System, used as an adjunct in interventional procedures, have NOT been established."

    Therefore, I cannot provide the requested information based on the provided text. The document is about the regulatory clearance for the device's intended use in the peripheral vasculature, not about detailed performance studies or acceptance criteria that would typically be found in a clinical study report or a more extensive submission.

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