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interface transfusion blood filter 35
Medical
Summary: The Interface Transfusion Blood Filter 35 is a medical device used to filter blood during transfusions, primarily to remove leukocytes and other impurities. It is typically used by hematologists and transfusion specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K851370 ↗
Decision Date
June 27, 1985
Product Code
CAK
Device Class
Class 2
Evidence
0 studies
The Interface Transfusion Blood Filter 35 was cleared through the FDA 510(k) pathway on June 27, 1985. Manufactured by Medical, it is classified as a Class 2 device under product code CAK.
What It Is
The Interface Transfusion Blood Filter 35 is designed to filter blood during transfusions, effectively removing leukocytes and other cellular debris. This process helps reduce the risk of febrile non-hemolytic transfusion reactions and other complications associated with transfusions. The device operates by utilizing a specialized filtration membrane that captures unwanted cells while allowing the passage of red blood cells and plasma.
Clinical Applications
This device is commonly used in transfusion medicine, particularly in settings where leukoreduction is necessary, such as in patients with a history of febrile reactions to transfusions or those undergoing chemotherapy. It is used in hospitals and blood banks, often by hematologists, oncologists, and transfusion specialists. Pediatric and immunocompromised patients are among the populations that may benefit from its use.
Indications for Use
The FDA indications suggest this device is used for filtering blood to remove leukocytes and other impurities during transfusions. It is particularly beneficial for patients who are at risk of transfusion reactions or require leukoreduced blood products.
Practical Considerations
The Interface Transfusion Blood Filter 35 is compatible with standard blood transfusion setups. Clinicians should ensure proper priming of the filter to avoid air embolism and maintain appropriate flow rates to ensure effective filtration. The device is typically available in sizes suitable for adult and pediatric patients.
Related Literature
The linked study compared processing times, platelet yields, and white blood cell content across several plateletapheresis systems. It found variability in performance among the systems, with some providing better leukoreduction. However, the study was limited by its focus on plateletapheresis rather than direct transfusion filtration, which may limit its applicability to the Interface Transfusion Blood Filter 35.
Frequently Asked Questions
What is Interface Transfusion Blood Filter 35 used for?
It is used to filter blood during transfusions to remove leukocytes and other impurities, reducing the risk of transfusion reactions.
What specialties typically use this device?
Hematologists, oncologists, and transfusion specialists commonly use this device in hospital and blood bank settings.
What are the FDA-cleared indications?
The device is indicated for filtering blood to remove leukocytes and impurities during transfusions, particularly for patients at risk of transfusion reactions.
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.