📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Hemodialysis treatment for patients who require extracorporeal blood purification because of inadequate kidney function.
- Use with an extracorporeal blood circuit and dialyzer to remove metabolic waste and excess fluid from the blood.
Clinical Applications
- Hemodialysis for patients with end-stage kidney disease.
- Hemodialysis for patients with acute kidney injury when renal replacement therapy is required.
- Removal of excess fluid and metabolic waste during a prescribed dialysis treatment.
- Use in a clinical dialysis setting by trained healthcare personnel with compatible dialysis supplies.
Practical Considerations
- The system requires compatible blood tubing, dialyzer, dialysate supplies and vascular access equipment; compatibility should be confirmed in the operator's manual and applicable labeling.
- Treatment requires vascular access, commonly an arteriovenous fistula, arteriovenous graft or dialysis catheter, and continuous monitoring by trained staff.
- The FDA record identifies the device as Class II and does not establish that it is MRI safe. It should not be taken into an MRI environment unless the specific labeling confirms its status.
- Potential treatment complications include hypotension, bleeding, infection, blood loss, air embolism, electrolyte or fluid shifts and clotting of the extracorporeal circuit.
- Routine inspection, disinfection, preventive maintenance and functional checks are required according to the manufacturer's instructions; the available record does not establish a fixed service life.
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.