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    K Number
    K252722
    Device Name
    Biopsy Forceps
    Manufacturer
    FEHLING Instruments GmbH
    Date Cleared
    2025-09-30

    (33 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K170726
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FEHLING Biopsy Forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.

    Device Description

    The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components:

    1. an actuating handle ergonomically designed for comfortable use,
    2. a flexible shaft,
    3. and surgical stainless steel cutting jaws.

    At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device.

    The product is provided single for use and sterile.

    AI/ML Overview

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