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acute hemodialysis tray cat 09-9540-7
Med-West
Summary: The acute hemodialysis tray cat 09-9540-7 is a medical device used for hemodialysis procedures, primarily by nephrologists and dialysis nurses. It facilitates vascular access for patients requiring acute dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K854612 ↗
Decision Date
January 3, 1986
Product Code
LFK
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on January 3, 1986, by Med-West. It is classified as a Class 2 device under product code LFK.
What It Is
The acute hemodialysis tray cat 09-9540-7 is a pre-packaged kit designed to assist in the setup and execution of hemodialysis procedures. It typically includes components necessary for establishing vascular access, such as catheters and sterile drapes. This device is essential in providing efficient and sterile conditions for acute dialysis treatment, ensuring patient safety and procedural efficacy.
Clinical Applications
This device is commonly used in hospital settings, particularly in nephrology departments and dialysis centers, for patients experiencing acute kidney failure or other conditions requiring urgent dialysis. It is utilized by healthcare professionals such as nephrologists, dialysis nurses, and interventional radiologists. The tray facilitates quick and effective vascular access, which is crucial for the timely initiation of dialysis in acute settings.
Indications for Use
The device is indicated for use in patients who require acute hemodialysis, often due to sudden kidney failure or severe electrolyte imbalances. It is suitable for patients in critical care settings where immediate dialysis access is necessary.
Practical Considerations
The tray typically comes in various sizes to accommodate different patient anatomies and is compatible with standard dialysis machines. Clinicians should ensure proper selection of catheter size and insertion technique to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the acute hemodialysis tray cat 09-9540-7 used for?
It is used for establishing vascular access in patients requiring acute hemodialysis.
What specialties typically use this device?
Nephrologists, dialysis nurses, and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing acute hemodialysis, such as those with sudden kidney failure.
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.