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modification to dbb-05 hemodialysis delivery system
Nikkiso
Summary: The modification to the DBB-05 Hemodialysis Delivery System by Nikkiso is 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
K061519 ↗
Decision Date
September 28, 2007
Product Code
KDI
Device Class
Class 2
Evidence
0 studies
The device modification was cleared through the FDA 510(k) pathway on September 28, 2007. Manufactured by Nikkiso, it is classified as a Class 2 device under product code KDI.
What It Is
The DBB-05 Hemodialysis Delivery System is a medical device designed to perform hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. This system includes modifications that enhance its efficiency and safety for both patients and operators. It typically involves a dialyzer, blood tubing, and a dialysis machine that controls the flow and pressure of blood and dialysate.
Clinical Applications
This device is commonly used in nephrology departments and dialysis centers for patients with chronic kidney disease or acute renal failure requiring hemodialysis. It is essential in outpatient dialysis clinics and hospital settings, providing life-sustaining treatment to patients with end-stage renal disease. The system is operated by trained nephrologists and dialysis technicians, ensuring precise and safe dialysis sessions.
Indications for Use
The device is indicated for use in patients requiring hemodialysis due to renal failure. It is suitable for individuals with chronic kidney disease or acute kidney injury who need regular dialysis to manage their condition.
Practical Considerations
The system is compatible with standard dialysis equipment and requires regular maintenance to ensure optimal performance. Clinicians should be trained in its operation and aware of any specific modifications that may affect its use. Proper sizing of dialyzers and blood tubing is crucial for effective treatment.
Frequently Asked Questions
What is the modification to DBB-05 hemodialysis system used for?
It is used for performing hemodialysis in patients with renal failure, filtering waste and excess fluids from the blood.
What specialties typically use this device?
Nephrologists and dialysis technicians in nephrology departments and dialysis centers use this device.
What are the FDA-cleared indications?
The device is indicated for hemodialysis treatment in patients with renal failure, 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.