Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    DEN150053
    Device Name
    FETAL PILLOW
    Date Cleared
    2017-07-27

    (617 days)

    Product Code
    Regulation Number
    884.4350
    Why did this record match?
    Product Code :

    PWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age >37 weeks.
    Device Description
    The Fetal Pillow is an inflatable balloon device which consists of the following components: - Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head. - Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube. - Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation. - Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon. - Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution. The Fetal Pillow is a single use, disposable, sterile device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1