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dideco lilliput 1 twin reservoir with phosphorilcholine insert surface in oxygenation ph i s i o
Dideco S.P.A.
Summary: The Dideco Lilliput 1 Twin Reservoir is a medical device used in oxygenation procedures, primarily for patients undergoing cardiac surgery. It is typically utilized by cardiovascular surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K001602 ↗
Decision Date
June 8, 2000
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The Dideco Lilliput 1 Twin Reservoir with phosphorilcholine insert surface was cleared through the FDA 510(k) pathway on June 8, 2000. It is manufactured by Dideco S.P.A. and classified as a Class 2 device under product code DTN.
What It Is
The Dideco Lilliput 1 Twin Reservoir is a component of an oxygenation system used during cardiopulmonary bypass procedures. It features a phosphorilcholine-coated surface designed to enhance biocompatibility and reduce inflammatory responses. This device helps in the efficient exchange of gases, ensuring that blood is adequately oxygenated during surgical procedures where the heart and lungs are temporarily bypassed.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass. It is essential in operations such as coronary artery bypass grafting (CABG) and heart valve repair or replacement. The device is typically used in hospitals by cardiovascular surgeons and perfusionists who manage the heart-lung machine during surgery.
Indications for Use
The Dideco Lilliput 1 Twin Reservoir is indicated for use in patients undergoing surgeries that require cardiopulmonary bypass. It is suitable for patients who need temporary support of the heart and lungs during complex cardiac procedures.
Practical Considerations
The device is designed to be compatible with standard cardiopulmonary bypass systems. It is important for clinicians to ensure proper integration with other components of the bypass circuit. The phosphorilcholine coating is intended to minimize blood activation and improve patient outcomes.
Frequently Asked Questions
What is the Dideco Lilliput 1 Twin Reservoir used for?
It is used for oxygenating blood during cardiopulmonary bypass procedures in cardiac surgeries.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings typically use this device.
What are the FDA-cleared indications?
It is indicated for use in patients undergoing surgeries requiring cardiopulmonary bypass, such as heart surgeries.
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.