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interface pre bypass prime filter
Medical
Summary: The interface pre bypass prime filter is a medical device used to filter fluids during surgical procedures, particularly in cardiopulmonary bypass. It is primarily used by cardiovascular surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K812240 ↗
Decision Date
August 25, 1981
Product Code
KRJ
Device Class
Class 2
Evidence
0 studies
This device 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 KRJ.
What It Is
The interface pre bypass prime filter is designed to remove particulate matter and air bubbles from fluids used in surgical procedures, especially during cardiopulmonary bypass. It ensures that the fluid entering the patient's circulation is free of contaminants, which is crucial in maintaining patient safety during surgery. The device operates by utilizing a fine mesh or membrane to trap unwanted particles and air, thereby preventing embolism and other complications.
Clinical Applications
This device is commonly used in cardiovascular surgeries, particularly during procedures that require cardiopulmonary bypass, such as open-heart surgery. It is typically employed in hospital operating rooms and is essential for ensuring the safety and efficacy of the bypass process. The primary users are cardiovascular surgeons and perfusionists who manage the heart-lung machine during surgery.
Indications for Use
The FDA indications suggest that this device is used to filter fluids in surgical settings to prevent the introduction of air and particulates into the patient's bloodstream. It is particularly indicated for use in procedures where blood is circulated outside the body, such as during cardiopulmonary bypass.
Practical Considerations
The device is typically available in various sizes to accommodate different surgical setups and patient needs. It should be compatible with standard cardiopulmonary bypass equipment. Proper technique in priming and connecting the filter is essential to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the interface pre bypass prime filter used for?
It is used to filter fluids during surgical procedures, particularly in cardiopulmonary bypass, to remove particulates and air bubbles.
What specialties typically use this device?
Cardiovascular surgery, specifically by cardiovascular surgeons and perfusionists during procedures involving cardiopulmonary bypass.
What are the FDA-cleared indications?
The device is indicated for filtering fluids in surgical settings to prevent air and particulates from entering the bloodstream, especially during cardiopulmonary bypass.
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.