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interface cardiotomy blood filter 50
Medical
Summary: The Interface Cardiotomy Blood Filter 50 is a medical device used to filter blood during cardiac procedures. It is primarily used by cardiac surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K823259 ↗
Decision Date
November 24, 1982
Product Code
JOD
Device Class
Class 2
Evidence
0 studies
The Interface Cardiotomy Blood Filter 50 was cleared through the FDA 510k pathway on November 24, 1982. Manufactured by Medical, it is classified as a Class 2 device under product code JOD.
What It Is
The Interface Cardiotomy Blood Filter 50 is designed to filter and remove particulate matter from blood collected during cardiotomy procedures. It works by allowing blood to pass through a filter membrane, capturing debris and preventing it from re-entering the patient's circulation. This device is essential in maintaining blood purity during cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that involve cardiopulmonary bypass. It is utilized by cardiac surgeons and perfusionists to ensure that the blood returned to the patient is free from potentially harmful particulates. The device is crucial in surgeries involving heart valve replacements or repairs, coronary artery bypass grafting, and other complex cardiac interventions.
Indications for Use
The FDA indications suggest that this device is used to filter blood during cardiac procedures, ensuring that any debris or particulate matter is removed before the blood is returned to the patient. It is indicated for use in patients undergoing surgeries that involve cardiotomy.
Practical Considerations
The Interface Cardiotomy Blood Filter 50 is typically compatible with standard cardiopulmonary bypass circuits. It is important to ensure proper sizing and integration into the bypass system to maintain optimal blood flow and filtration efficiency. Clinicians should be familiar with the setup and operation of the filter to maximize its effectiveness.
Frequently Asked Questions
What is Interface Cardiotomy Blood Filter 50 used for?
It is used to filter and remove particulate matter from blood during cardiac surgeries, ensuring blood purity.
What specialties typically use this device?
Cardiac surgeons and perfusionists in operating rooms during cardiac procedures.
What are the FDA-cleared indications?
The device is indicated for filtering blood during cardiac procedures to remove debris before returning blood to the patient.
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.