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fresenius a2008 hemodialysis machine expansion mod
Seratronics
Summary: The Fresenius A2008 Hemodialysis Machine Expansion Mod is a medical device used for hemodialysis treatment in patients with renal failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K844750 ↗
Decision Date
February 15, 1985
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The Fresenius A2008 Hemodialysis Machine Expansion Mod was cleared by the FDA via the 510(k) pathway on February 15, 1985. Manufactured by Seratronics, it is classified as a Class 2 device under product code FKQ.
What It Is
The Fresenius A2008 Hemodialysis Machine Expansion Mod is an advanced medical device designed to perform hemodialysis, a process that filters waste products and excess fluids from the blood when the kidneys are no longer able to do so. It operates by circulating the patient's blood through a dialyzer, where it is cleaned before being returned to the body. This device is crucial for managing patients with chronic kidney disease or acute kidney injury.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients requiring regular hemodialysis treatments. It is essential in nephrology, particularly for patients with end-stage renal disease (ESRD) who need ongoing dialysis to maintain their health. The machine is used by trained healthcare professionals, including nephrologists and dialysis nurses, to ensure safe and effective treatment.
Indications for Use
The FDA indications for this device include its use in patients with renal failure who require hemodialysis. It is suitable for individuals with chronic kidney disease or acute kidney injury who need assistance in filtering waste from their blood.
Practical Considerations
Clinicians should ensure compatibility with the patient's vascular access type and consider the machine's settings for optimal dialysis delivery. Regular maintenance and calibration are necessary to ensure accurate and safe operation. The device is compatible with standard hemodialysis protocols and equipment.
Frequently Asked Questions
What is the Fresenius A2008 Hemodialysis Machine Expansion Mod used for?
It is used for performing hemodialysis in patients with renal failure to filter waste and excess fluid from the blood.
What specialties typically use this device?
Nephrology and dialysis technicians typically use this device in clinical settings such as dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for use in patients with renal failure requiring hemodialysis, including those with chronic kidney disease or acute kidney injury.
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.