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510(k) Data Aggregation

    K Number
    K091958
    Device Name
    BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
    Manufacturer
    GLENVEIGH SURGICAL, LLC
    Date Cleared
    2010-04-30

    (303 days)

    Product Code
    OQY
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLENVEIGH SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Belfort-Dildy Obstetric Tamponade System (OTS) is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.
    Device Description
    The Belfort-Dildy Obstetric Tamponade System (OTS) is a disposable, multiple lumen catheter attached to an inflatable balloon system designed to provide tamponade for controlling hemorrhage from the uterus and vagina. The device consists of two inflatable balloons: The upper uterine balloon is inflated inside the uterus and the lower vaginal balloon is inflated inside the vagina. Inflation is accomplished with isotonic intravenous fluid such as normal saline or Ringers Lactate. The uterine balloon catheter has separate lumens to enable inflation/deflation, irrigation and drainage. The vaginal balloon catheter has a lumen to enable inflation/deflation. The uterine and vaginal balloons are permanently assembled and are not to be separated. The device may be retained in position for up to 24 hours in the post-operative mode of treatment. The Belfort-Dildy Obstetric Tamponade System (OTS) is supplied sterile in peel open pouches for one time use to a single patient.
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    K Number
    K093904
    Device Name
    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
    Manufacturer
    GLENVEIGH SURGICAL, LLC
    Date Cleared
    2010-04-14

    (113 days)

    Product Code
    KNA
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLENVEIGH SURGICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
    Device Description
    The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.
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