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510(k) Data Aggregation

    K Number
    K123943
    Device Name
    AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
    Manufacturer
    AMECO MEDICAL INDUSTRIES
    Date Cleared
    2013-04-02

    (103 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 :

    AMECATH DUAL LUMEN HEMODIALYSIS CATHETER

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

    "Amecath Dual Lumen Implanted Hemodialysis Catheter" is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane catheter designed for percutaneous insertion or insertion via cutdown.

    Repair Kit is designed to replace worn or damaged extension connector adapters on the all catheter models:

    • . PDLC
    • PYDLC .
    • P2TC .
    • PXDLC .

    Catheters are not intended for pediatric use.

    Device Description

    "Amecath Dual Lumen Implanted Hemodialysis Catheter and Repair Kit"

    AI/ML Overview

    This is a letter for the clearance of an Amended Dual Lumen Implanted Hemodialysis Catheter and Repair Kit. We can't determine the acceptance criteria and study from this document. This kind of information is usually located in the 510(k) summary document, which is not provided.

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