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510(k) Data Aggregation

    K Number
    K983412
    Device Name
    MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Date Cleared
    1998-12-10

    (73 days)

    Product Code
    LJS,INI
    Regulation Number
    880.5970
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medcomp H-Cath Central Venous Access Catheter is designed for long-term central venous access. It can be used for total parenteral nutrition (TPN), infusion of I.V. liquids, blood, blood products and drugs. It can also be used for repeated withdrawal of blood samples.

    Device Description

    Medcomp H-Cath Triple Lumen Central Venous Access Catheter

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment. This document is a 510(k) clearance letter from the FDA for a medical device (Medcomp H-Cath Triple Lumen Central Venous Access Catheter), confirming its substantial equivalence to a predicate device. It does not include the results of any performance studies or details about their methodology.

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