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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 ?
510(k)
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.
FDA-Cleared Indications
- Use in newborns and infants requiring extracorporeal circulation during cardiac surgery.
- Use as an oxygenator during cardiopulmonary bypass procedures.
Clinical Applications
- Oxygenation and carbon dioxide removal during neonatal cardiac surgery.
- Oxygenation and carbon dioxide removal during infant cardiac surgery.
- Use with a cardiopulmonary bypass circuit when extracorporeal circulation is required for repair of congenital heart disease.
Practical Considerations
- The device is intended for neonatal and infant patients; the appropriate model and flow range must match the patient and the perfusion circuit.
- It must be integrated with compatible cardiopulmonary bypass equipment and prepared according to the manufacturer’s instructions, including the specified priming volume.
- Use requires trained cardiac surgeons, perfusionists and operating-room staff experienced in pediatric cardiopulmonary bypass.
- The phospholipidic surface treatment does not eliminate the need for standard anticoagulation, monitoring and circuit-management practices.
- This is an extracorporeal device and is not implanted or worn during MRI; MRI compatibility is therefore not generally applicable, although the complete bypass setup should be kept outside the MRI environment.
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.