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lilliput phospholypidic inert surface in oxygenation ph i s i o infant hollow fibre oxygenator model d902
Dideco S.P.A.
Summary: The Lilliput PH.I.S.I.O Infant Oxygenator is a specialized device used in neonatal and pediatric cardiac surgery to oxygenate blood. It is primarily used by pediatric cardiac surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K001021 ↗
Decision Date
April 25, 2000
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Lilliput PH.I.S.I.O Infant Oxygenator, manufactured by Dideco S.P.A., received FDA clearance via the 510(k) pathway on April 25, 2000. It is classified as a Class 2 device under product code DTZ.
What It Is
The Lilliput PH.I.S.I.O Infant Oxygenator is a hollow fiber oxygenator designed for use in extracorporeal circulation during infant cardiac surgeries. It works by facilitating gas exchange, allowing for the removal of carbon dioxide and the addition of oxygen to the blood. The phospholipidic inert surface reduces the risk of clotting and inflammatory responses, which is crucial in delicate neonatal and pediatric populations.
Clinical Applications
This device is commonly used in neonatal and pediatric cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass. It is essential for maintaining adequate oxygenation in infants with congenital heart defects undergoing surgical repair. Pediatric cardiac surgeons and perfusionists in specialized cardiac centers are the primary users of this device.
Indications for Use
The Lilliput PH.I.S.I.O Infant Oxygenator is indicated for use in infants requiring cardiopulmonary bypass during cardiac surgery. It is specifically designed for patients with congenital heart conditions that necessitate surgical intervention.
Practical Considerations
The device is typically sized for infants, ensuring compatibility with the smaller blood volumes and flow rates in this population. It is important to ensure proper setup and priming to minimize air embolism risks. Compatibility with standard cardiopulmonary bypass equipment is generally expected.
Frequently Asked Questions
What is the Lilliput PH.I.S.I.O Infant Oxygenator used for?
It is used for oxygenating blood during infant cardiac surgeries requiring cardiopulmonary bypass.
What specialties typically use this device?
Pediatric cardiac surgery and perfusion specialists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in infants requiring cardiopulmonary bypass during cardiac surgery, particularly for congenital heart defects.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.