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hd-400-a b c hemodialysis systems accessories
Water Pure
Summary: The hd-400-a b c hemodialysis systems accessories by Water Pure are used in hemodialysis procedures to support renal function in patients with kidney failure. They are typically utilized by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K873487 ↗
Decision Date
October 23, 1987
Product Code
FIP
Device Class
Class 2
Evidence
0 studies
The hd-400-a b c hemodialysis systems accessories were cleared through the FDA 510(k) pathway on October 23, 1987. Manufactured by Water Pure, this device is classified as Class 2 under product code FIP.
What It Is
The hd-400-a b c hemodialysis systems accessories are components used in conjunction with hemodialysis machines to facilitate the removal of waste products and excess fluid from the blood of patients with renal failure. These accessories may include tubing, connectors, and other necessary components that ensure the proper functioning of the dialysis system. They are essential for maintaining the efficiency and safety of the dialysis process.
Clinical Applications
These accessories are commonly used in dialysis centers and hospitals where patients undergo regular hemodialysis treatments. Nephrologists and dialysis technicians use them to ensure that the dialysis machines operate effectively and safely. They are crucial for patients with chronic kidney disease or acute kidney injury who require regular dialysis to manage their condition.
Indications for Use
The FDA indications suggest that these accessories are intended for use in hemodialysis procedures, which are necessary for patients with compromised kidney function. This includes individuals with end-stage renal disease or acute kidney failure requiring dialysis support.
Practical Considerations
When using the hd-400-a b c hemodialysis systems accessories, clinicians should ensure compatibility with existing dialysis machines. Proper sizing and secure connections are crucial to prevent leaks and ensure patient safety. Regular maintenance and inspection are recommended to maintain optimal performance.
Frequently Asked Questions
What is hd-400-a b c hemodialysis systems accessories used for?
They are used to support hemodialysis procedures by facilitating the removal of waste and excess fluid from the blood in patients with kidney failure.
What specialties typically use this device?
Nephrologists and dialysis technicians primarily use these devices in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The accessories are indicated for use in hemodialysis procedures for patients with renal failure, including those with end-stage renal disease.
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.