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interface pre bypass prime filter 90
Medical
Summary: The Interface Pre Bypass Prime Filter 90 is a medical device used in surgical procedures to filter fluids before bypass. It is typically used by surgeons and clinical teams in operating rooms.
FDA Clearance Information
Pathway
510K
Number
K812244 ↗
Decision Date
August 25, 1981
Product Code
KRJ
Device Class
Class 2
Evidence
0 studies
The Interface Pre Bypass Prime Filter 90 was cleared through the FDA 510(k) pathway on August 25, 1981. It is manufactured by Medical and classified as a Class 2 device under product code KRJ.
What It Is
The Interface Pre Bypass Prime Filter 90 is designed to filter fluids in medical settings, particularly during surgical procedures requiring bypass. It helps remove particulates and potential contaminants from fluids before they enter the bypass circuit, ensuring patient safety. This device is crucial in maintaining the sterility and integrity of the fluid pathways in surgical environments.
Clinical Applications
This device is commonly used in cardiac surgery and other procedures involving cardiopulmonary bypass. It is employed in operating rooms by surgical teams to ensure that the fluids used in bypass circuits are free from particulates. The filter is particularly relevant in settings where maintaining sterile and particulate-free fluid pathways is critical, such as in cardiovascular and thoracic surgeries.
Indications for Use
The FDA indications suggest that this device is intended for use in filtering fluids during surgical procedures requiring bypass. It is suitable for patients undergoing surgeries where fluid filtration is necessary to prevent contamination and ensure the safety of the bypass circuit.
Practical Considerations
The Interface Pre Bypass Prime Filter 90 should be compatible with standard bypass equipment. Clinicians should ensure proper sizing and compatibility with the existing surgical setup. It is important to follow the manufacturer's guidelines for installation and use to maximize efficacy and safety.
Frequently Asked Questions
What is Interface Pre Bypass Prime Filter 90 used for?
It is used to filter fluids during surgical procedures requiring bypass, ensuring the removal of particulates and contaminants.
What specialties typically use this device?
This device is typically used by cardiovascular and thoracic surgeons during procedures involving cardiopulmonary bypass.
What are the FDA-cleared indications?
The device is indicated for filtering fluids in surgical procedures requiring bypass to ensure patient safety by removing particulates.
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.