📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during extracorporeal circulation for cardiac surgery in infants.
- Use as a blood oxygenator during cardiopulmonary bypass when temporary gas exchange is required.
Clinical Applications
- Cardiopulmonary bypass during surgical repair of congenital heart defects in infants.
- Extracorporeal blood oxygenation during infant cardiac surgery.
- Removal of carbon dioxide from blood during cardiopulmonary bypass.
- Addition of oxygen to blood during extracorporeal circulation.
Practical Considerations
- The device is intended for infant-sized blood volumes and flow rates; the perfusion team must select the appropriate circuit configuration and operating parameters.
- It is used with a cardiopulmonary bypass circuit and requires proper priming, de-airing, monitoring and connection by trained cardiac-surgery personnel.
- The phospholipidic inert surface is intended to reduce blood-surface interactions, but it does not eliminate the risks of clotting, bleeding, inflammation or air embolism.
- The FDA record identifies this as a blood oxygenator, not an implantable device. MRI safety should not be assumed; the complete oxygenator and bypass circuit should be kept out of the MRI environment unless current manufacturer labeling specifically permits use.
- Contraindications, warnings, maximum flow rates, blood-contact requirements and other handling limits should be taken from the current device labeling and instructions for use.
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.