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510(k) Data Aggregation

    K Number
    K022257
    Device Name
    VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
    Manufacturer
    VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
    Date Cleared
    2002-10-04

    (84 days)

    Product Code
    DRC
    Regulation Number
    870.1390
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VOMED trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. VOMED trocars and trocar sleeves then allow endoscopic instruments, thoracoscopes, laparoscopes, a tube or a channel, and accessory devices to be inserted and used during cardiac surgery procedures.

    VOMED adapters, tube connectors, caps and plugs, stopcocks and valves are noninvasive, reusable devices for use in cardiovascular applications to interconnect tubing and other devices during extracorporeal bypass procedures, effectively establishing a conduit between the devices for the flow of blood and other extracorporeal fluids.

    Device Description

    VOMED Trocars and Adapters, Connectors, Stopcocks and Manifolds

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to VOMED Volzer Medizintechnik GmbH & Co. regarding the clearance of their Trocars and Adapters, Connectors, Stopcocks and Manifolds. This document does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory clearance letter, not a study report.

    Therefore, I cannot extract the requested information from the given text.

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