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510(k) Data Aggregation

    K Number
    K990514
    Device Name
    MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1999-03-09

    (19 days)

    Product Code
    DTP
    Regulation Number
    870.4230
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR

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

    The Bard Quantum CVR is designed to function in an extracorporeal circuit. The filtered cardiotomy/reservoir receives dynamic blood from: 1) Venous return; 2) Intracardiac suction; 3) Ventricular vent devices; 4) Arterial-venous shunts. It defoams, filters and stores this blood prior to returning it to the circuit.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Bard Quantum CVR) and a statement of its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or a detailed premarket submission summary.

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

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