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510(k) Data Aggregation

    K Number
    K094048
    Device Name
    PERCUPRO MESSENGER BALLOON CATHETER
    Manufacturer
    CARDIOSOLUTIONS INC
    Date Cleared
    2011-07-14

    (560 days)

    Product Code
    DYG
    Regulation Number
    870.1240
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K051137,K961999,K010853,K083384
    Why did this record match?
    Device Name :

    PERCUPRO MESSENGER BALLOON CATHETER

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

    The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.

    Device Description

    The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.

    AI/ML Overview

    This document does not contain information about a study proving that a device meets acceptance criteria, an AI/ML device, or a standalone algorithm.

    The document is a 510(k) summary for the Percu-Pro™ Messenger Balloon Catheter, which is a physical medical device (a catheter). The summary details its design, intended use, and comparison to predicate devices to establish substantial equivalence, rather than providing performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI system.

    Therefore, I cannot provide the requested information.

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