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510(k) Data Aggregation

    K Number
    K072051
    Device Name
    NOVATOME, MODEL: SU101-50
    Manufacturer
    SCHOLTEN SURGICAL INSTRUMENTS, INC.
    Date Cleared
    2007-10-03

    (69 days)

    Product Code
    DWZ
    Regulation Number
    870.4075
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCHOLTEN SURGICAL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scholten Novatome™ is a surgical device used to perform endomyocardial biopsies.
    Device Description
    The Scholten Surgical Instruments, Inc. Novatome is a manually operated hand held surgical instrument designed to remove biopsy samples from the right or left ventricle of the Human Heart via percutaneous venous or arterial access. Specifically via the internal Jugular or subclavian veins or the femoral artery. The device consists of three main parts. The cutting jaws, a polymer coated flexible shaft, and an actuating handle. At the distal end of the forceps is a pair of jaws used to obtain the heart tissue samples. At the proximal end of the forceps is the actuation handle used to activate the jaws and steer the device. The device cutting jaws are single action in that one of the jaws is fixed and is attached to the end of the flexible shaft and the other jaw is movable and is attached to a link that is welded to the end of the actuation wire. The single moving jaw, the distance the jaws open, as well as the orientation of the jaw work in combination to control the amount of tissue obtained. The Novatome's actuation handle is made of an advanced high-performance polymer. The jaws, actuation wire, and other mechanical parts are made of stainless steel. The flexible shaft sheath material is Fluoropolymer tubing. The Novatome™ will be available in 9,8,7, and 6 French cutting jaw sizes, with flexible shaft lengths of 50, 70, and 100cm lengths.
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