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model 7200 hemodialysis delivery system
Bd Becton Dickinson Vacutainer Systems Preanalytic
Summary: The Model 7200 Hemodialysis Delivery System is a medical device used for hemodialysis treatment in patients with kidney failure. It is typically used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K800330 ↗
Decision Date
April 8, 1980
Product Code
FKP
Device Class
Class 2
Evidence
0 studies
The Model 7200 Hemodialysis Delivery System was cleared by the FDA via the 510(k) pathway on April 8, 1980. It is manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic and is classified as a Class 2 device.
What It Is
The Model 7200 Hemodialysis Delivery System is a 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. The system operates by circulating the patient's blood through a dialyzer, where it is cleaned before being returned to the body. This device is critical in managing patients with end-stage renal disease (ESRD) or acute kidney injury.
Clinical Applications
This device is commonly used in hospital dialysis units, outpatient dialysis centers, and home dialysis settings. It is primarily used by nephrologists and dialysis technicians to treat patients with chronic kidney disease or acute kidney injury requiring renal replacement therapy. The system is suitable for adult and pediatric patients who need regular dialysis sessions to manage their kidney function.
Indications for Use
The Model 7200 is indicated for patients with kidney failure who require hemodialysis to remove waste products and excess fluid from their blood. It is used in patients with conditions such as chronic kidney disease or acute kidney injury.
Practical Considerations
The Model 7200 system is compatible with standard dialysis consumables and requires routine maintenance to ensure optimal performance. Clinicians should be familiar with the device's operation and troubleshooting procedures to manage any technical issues during dialysis sessions.
Related Literature
The linked study focuses on genetic kidney diseases (GKDs), which often lead to chronic kidney disease requiring dialysis. It explores the genetic causes and potential for gene editing technologies to model these diseases. While the study provides insights into GKDs, it does not directly evaluate the Model 7200 Hemodialysis Delivery System. Limitations include its focus on genetic modeling rather than direct clinical applications.
Frequently Asked Questions
What is the Model 7200 Hemodialysis Delivery System used for?
It is used for performing hemodialysis in patients with kidney failure to remove waste products and excess fluids from the blood.
What specialties typically use this device?
Nephrologists and dialysis technicians in nephrology and dialysis centers typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with kidney failure who require hemodialysis to manage their condition.
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.