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hemodialysis sps model 550 code 5m1309
Travenol Laboratories
Summary: The Hemodialysis SPS Model 550 by Travenol Laboratories is a medical device used in hemodialysis to treat patients with kidney failure. It is primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K872364 ↗
Decision Date
October 13, 1987
Product Code
FII
Device Class
Class 2
Evidence
0 studies
The Hemodialysis SPS Model 550 was cleared through the FDA 510(k) pathway on October 13, 1987. Manufactured by Travenol Laboratories, it is classified as a Class 2 device under product code FII.
What It Is
The Hemodialysis SPS Model 550 is a device designed for use in hemodialysis, a process that filters waste and excess fluids from the blood when the kidneys are not functioning properly. It operates by circulating the patient's blood through a dialyzer, or artificial kidney, where toxins are removed. This device is essential in managing chronic kidney disease and acute kidney injury.
Clinical Applications
This device is commonly used in dialysis centers and hospitals, where it supports patients with end-stage renal disease (ESRD). Nephrologists and dialysis nurses typically operate the device during dialysis sessions, which can occur multiple times per week. It is suitable for adult and pediatric patients who require renal replacement therapy.
Indications for Use
The Hemodialysis SPS Model 550 is indicated for patients with kidney failure who need dialysis to remove waste products and excess fluid from their blood. It is used in both chronic and acute settings, providing life-sustaining treatment for those with compromised kidney function.
Practical Considerations
The device requires proper setup and calibration by trained personnel to ensure effective dialysis treatment. Compatibility with various dialyzers and bloodline sets should be considered. Regular maintenance and adherence to safety protocols are crucial for optimal performance.
Frequently Asked Questions
What is Hemodialysis SPS Model 550 used for?
It is used for hemodialysis treatment in patients with kidney failure to remove waste and excess fluid from the blood.
What specialties typically use this device?
Nephrologists and dialysis technicians in nephrology and renal care settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with kidney failure requiring dialysis to manage waste and fluid removal.
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.