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510(k) Data Aggregation

    K Number
    K971897
    Device Name
    CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)
    Manufacturer
    MEDRON, INC.
    Date Cleared
    1997-10-21

    (152 days)

    Product Code
    LFK
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K914936
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indication for use of the MEDRON CAVH Catheter is for accessing the vascular system for continuous arteriovenous hemofiltration.

    Device Description

    Catheter

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a medical device (MEDRON CAVH Catheter), outlining its intended use, classification, and substantial equivalence to a predicate device, along with the FDA's clearance letter. It does not include details on specific performance acceptance criteria or results from a study designed to demonstrate compliance with those criteria.

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