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510(k) Data Aggregation
K Number
K091958Device Name
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
Manufacturer
GLENVEIGH SURGICAL, LLC
Date Cleared
2010-04-30
(303 days)
Product Code
OQY
Regulation Number
884.4530Why 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
K093904Device Name
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
Manufacturer
GLENVEIGH SURGICAL, LLC
Date Cleared
2010-04-14
(113 days)
Product Code
KNA
Regulation Number
884.4530Why 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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