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510(k) Data Aggregation

    K Number
    K983594
    Device Name
    EMBRYO TRANSFER CATHETERS/SETS
    Manufacturer
    COOK OB/GYN
    Date Cleared
    1998-12-21

    (69 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EMBRYO TRANSFER CATHETERS/SETS

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

    The Embryo Transfer Catheters/Sets are used to place embryos into the uterine cavity.

    Device Description

    The Embryo Transfer Catheters/Sets are used for transferring IVF embryos into the uterine cavity. The materials used in these devices are NRT (TFE), polyethylene, Echosight polyethylene, and stainless steel. Biocompatibility is assured.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for an embryo transfer catheter/set. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The provided text focuses on the regulatory submission process, device description, and substantial equivalence, not performance testing against specific acceptance criteria. Therefore, the requested information cannot be extracted from this document.

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