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interface 20 micron transfusion bld f
Abbott Laboratories
Summary: The Interface 20 Micron Transfusion Bld F is a medical device used in blood transfusion procedures. It is primarily utilized by hematologists and transfusion specialists to ensure the safe and effective delivery of blood products.
FDA Clearance Information
Pathway
510K
Number
K810855 ↗
Decision Date
April 21, 1981
Product Code
CAK
Device Class
Class 2
Evidence
0 studies
The Interface 20 Micron Transfusion Bld F was cleared through the FDA 510k pathway on April 21, 1981. Manufactured by Abbott Laboratories, it is classified as a Class 2 device under product code CAK.
What It Is
The Interface 20 Micron Transfusion Bld F is a specialized filter used in blood transfusion procedures to remove microaggregates and other potential contaminants from blood products. This ensures that transfused blood is as safe as possible for the recipient, reducing the risk of complications such as embolism or immune reactions. The device operates by filtering blood through a 20-micron mesh, capturing unwanted particles while allowing the passage of essential blood components.
Clinical Applications
This device is commonly used in hospital settings, particularly in transfusion medicine and hematology departments. It is essential in procedures involving the transfusion of whole blood, red blood cells, or platelets, especially in patients with compromised immune systems or those at risk of transfusion-related complications. Pediatric and oncology patients, who often require precise and safe blood product administration, are typical recipients of transfusions using this device.
Indications for Use
The FDA indications for this device involve its use in filtering blood products during transfusions to prevent the transmission of microaggregates and other contaminants. It is particularly indicated for patients who are at higher risk of transfusion-related complications.
Practical Considerations
The Interface 20 Micron Transfusion Bld F is compatible with standard transfusion setups and can be easily integrated into existing transfusion protocols. Clinicians should ensure proper priming of the filter to avoid air embolism and maintain the integrity of the blood components during the transfusion process.
Frequently Asked Questions
What is Interface 20 Micron Transfusion Bld F used for?
It is used to filter blood products during transfusions, removing microaggregates and contaminants to ensure patient safety.
What specialties typically use this device?
Hematology and transfusion medicine specialists commonly use this device, particularly in hospital settings.
What are the FDA-cleared indications?
The device is indicated for filtering blood products during transfusions to prevent complications from microaggregates and contaminants.
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.