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interface cardiotomy blood filter 51
Medical
Summary: The Interface Cardiotomy Blood Filter 51 is a medical device used to filter blood during cardiopulmonary bypass procedures. It is primarily used by cardiovascular surgeons and perfusionists in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K823260 ↗
Decision Date
November 24, 1982
Product Code
JOD
Device Class
Class 2
Evidence
0 studies
The Interface Cardiotomy Blood Filter 51 was cleared through the FDA 510(k) pathway on November 24, 1982. It is manufactured by Medical and classified as a Class 2 device under product code JOD.
What It Is
The Interface Cardiotomy Blood Filter 51 is designed to remove particulate matter and microemboli from blood during cardiopulmonary bypass procedures. It works by filtering the blood collected from the surgical field, ensuring that only clean blood is returned to the patient. This device is crucial in reducing the risk of complications associated with emboli during cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass, such as coronary artery bypass grafting or valve replacement surgeries. It is utilized by cardiovascular surgeons and perfusionists to maintain blood purity and prevent embolic events. The typical patient population includes those undergoing open-heart surgery, where blood filtration is critical for patient safety.
Indications for Use
The Interface Cardiotomy Blood Filter 51 is indicated for use in filtering blood during cardiopulmonary bypass procedures. It is specifically designed for patients undergoing cardiac surgeries where blood filtration is necessary to prevent complications from emboli.
Practical Considerations
The device is typically available in various sizes to accommodate different patient needs and surgical setups. It is compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper integration into the bypass system and verify filter integrity before use.
Frequently Asked Questions
What is Interface Cardiotomy Blood Filter 51 used for?
It is used to filter blood during cardiopulmonary bypass procedures to remove particulate matter and microemboli.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists typically use this device during cardiac surgeries.
What are the FDA-cleared indications?
It is indicated for filtering blood during cardiopulmonary bypass procedures in cardiac 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.