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510(k) Data Aggregation

    K Number
    K971925
    Device Name
    MEDCOMP BIO-FLEX CS CATHETER (CS100)
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Date Cleared
    1998-02-23

    (276 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDCOMP BIO-FLEX CS CATHETER (CS100)

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

    The Medcomp Bio-Flex™ CS Catheter with Adjustable Cuff is designed for long term hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Although this catheter may be inserted into the subclavian vein, the internal jugular is the preferred site.

    Device Description

    Medcomp Bio-Flex™ CS Catheter

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Medcomp BioFlex™ CS Catheter, which primarily addresses regulatory approval based on substantial equivalence to a predicate device. It does not contain details about specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

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