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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 cardiotomy procedures. It is primarily used by cardiac surgeons and perfusionists in surgical settings.
FDA Clearance Information
Pathway
510K
Number
K812243 ↗
Decision Date
August 25, 1981
Product Code
JOD
Device Class
Class 2
Evidence
0 studies
The Interface Cardiotomy Blood Filter 51 was cleared through the FDA 510k pathway on August 25, 1981. Manufactured by Medical, it is classified as a Class 2 device under product code JOD.
What It Is
The Interface Cardiotomy Blood Filter 51 is designed to filter blood during cardiotomy procedures, removing particulate matter and air emboli. It operates by allowing blood to pass through a filter medium, capturing debris and ensuring cleaner blood is returned to the patient. This device is crucial in maintaining blood purity during cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during open-heart surgeries where cardiopulmonary bypass is employed. It is essential for procedures requiring blood filtration to prevent complications from particulate matter. Cardiac surgeons and perfusionists are the primary users, ensuring patient safety during complex surgical interventions.
Indications for Use
The FDA-cleared indications suggest this device is used for patients undergoing cardiac surgery where blood filtration is necessary. It is suitable for conditions requiring cardiotomy and cardiopulmonary bypass.
Practical Considerations
The Interface Cardiotomy Blood Filter 51 is typically compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper sizing and integration with existing surgical equipment. Technique considerations include ensuring the filter is correctly positioned to maximize efficiency.
Frequently Asked Questions
What is Interface Cardiotomy Blood Filter 51 used for?
It is used to filter blood during cardiac surgeries, removing debris and air emboli to ensure safe blood reinfusion.
What specialties typically use this device?
Cardiac surgery and perfusion are the primary specialties that utilize this device during surgical procedures.
What are the FDA-cleared indications?
The device is indicated for use in cardiac surgeries requiring blood filtration to remove particulate matter and air emboli.
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.