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lilliput phospholypidic inert surface in oxygenation ph i s i o infant newborn hollow fiber oxygenator
Dideco S.P.A.
Summary: The Lilliput Phospholypidic Inert Surface Oxygenator is a medical device used in neonatal care to provide oxygenation support during cardiac surgery. It is primarily used by pediatric cardiac surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K991737 ↗
Decision Date
February 17, 2000
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The Lilliput Oxygenator received FDA clearance via the 510k pathway on February 17, 2000. Manufactured by Dideco S.P.A., it is classified as a Class 2 device.
What It Is
The Lilliput Phospholypidic Inert Surface Oxygenator is a hollow fiber oxygenator designed for use in newborns and infants. It facilitates efficient gas exchange by providing a surface for oxygen and carbon dioxide transfer during extracorporeal circulation. The device's phospholipidic coating minimizes blood activation and reduces the risk of clot formation, making it suitable for delicate neonatal procedures.
Clinical Applications
This device is commonly used during neonatal and infant cardiac surgeries, where cardiopulmonary bypass is required. It is particularly relevant in pediatric cardiac surgery settings, where maintaining optimal oxygenation and minimizing blood trauma are critical. The device is used in hospitals with specialized pediatric cardiac units, catering to newborns with congenital heart defects.
Indications for Use
The oxygenator is indicated for use in newborns and infants requiring extracorporeal circulation support during cardiac surgery. It is specifically designed for patients with conditions necessitating cardiopulmonary bypass, such as congenital heart anomalies.
Practical Considerations
The Lilliput Oxygenator is typically available in sizes suitable for neonatal and infant patients. It is compatible with standard cardiopulmonary bypass systems. Clinicians should ensure proper integration with existing perfusion equipment and be aware of the specific priming volume required for optimal function.
Frequently Asked Questions
What is the Lilliput Phospholypidic Inert Surface Oxygenator used for?
It is used to provide oxygenation support during neonatal and infant cardiac surgeries requiring cardiopulmonary bypass.
What specialties typically use this device?
Pediatric cardiac surgeons and perfusionists in specialized cardiac surgery units use this device.
What are the FDA-cleared indications?
The device is indicated for use in newborns and infants needing extracorporeal circulation support during cardiac surgery.
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.