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510(k) Data Aggregation
K Number
DEN150053Device Name
FETAL PILLOW
Manufacturer
Date Cleared
2017-07-27
(617 days)
Product Code
Regulation Number
884.4350Why 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.
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