đź“‹ FDA Reference
dideco micro 40 ph i s i o phosphorylcholine insert surface in oxgenation newborn infant arterial filter
Cobe Cardiovascular
Summary: The Dideco Micro 40 Phisio is a specialized arterial filter used in oxygenation systems for newborn infants. It is primarily utilized by pediatric cardiologists and cardiac surgeons in neonatal intensive care settings.
FDA Clearance Information
Pathway
510K
Number
K002493 ↗
Decision Date
November 30, 2000
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Dideco Micro 40 Phisio was cleared through the FDA 510(k) pathway on November 30, 2000. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 medical device under product code DTM.
What It Is
The Dideco Micro 40 Phisio is an arterial filter designed for use in neonatal oxygenation systems. It features a phosphorylcholine-coated surface to enhance biocompatibility and reduce the risk of clot formation. This device is integral in extracorporeal membrane oxygenation (ECMO) circuits, ensuring the safe and effective removal of microemboli and other particulates from the blood.
Clinical Applications
This device is commonly used in neonatal intensive care units (NICUs) during procedures requiring ECMO, such as in cases of severe respiratory or cardiac failure in newborns. Pediatric cardiologists and cardiac surgeons rely on it to maintain optimal blood filtration and oxygenation in critically ill infants. Its use is crucial in managing conditions like congenital heart defects or persistent pulmonary hypertension of the newborn.
Indications for Use
The Dideco Micro 40 Phisio is indicated for use in newborn infants who require arterial blood filtration during oxygenation therapy. It is particularly suited for infants with conditions necessitating ECMO support, ensuring the removal of harmful particulates from the bloodstream.
Practical Considerations
The device is designed to be compatible with standard ECMO systems used in NICUs. It is important to ensure proper sizing and integration into the oxygenation circuit to maintain optimal function. Clinicians should be trained in its installation and monitoring to prevent complications.
Frequently Asked Questions
What is Dideco Micro 40 Phisio used for?
It is used for arterial blood filtration in neonatal oxygenation systems, particularly during ECMO therapy.
What specialties typically use this device?
Pediatric cardiologists and cardiac surgeons in neonatal intensive care settings.
What are the FDA-cleared indications?
It is indicated for use in newborn infants requiring arterial blood filtration during oxygenation therapy, especially in ECMO circuits.
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.