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sansin tubing sets for hemodialysis
Jiangxi Sanxin Medtec
Summary: The Sansin Tubing Sets for Hemodialysis are used in dialysis procedures to facilitate blood flow between the patient and the dialysis machine. They are primarily used by nephrologists and dialysis technicians in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K202796 ↗
Decision Date
September 6, 2021
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The Sansin Tubing Sets for Hemodialysis were cleared through the FDA 510(k) pathway on September 6, 2021. Manufactured by Jiangxi Sanxin Medtec, this device is classified as Class 2 under product code FJK.
What It Is
Sansin Tubing Sets for Hemodialysis are medical devices designed to connect a patient's vascular access to a dialysis machine. These tubing sets are essential for the safe and efficient transfer of blood during hemodialysis sessions. They typically include arterial and venous lines, ensuring proper blood flow and minimizing the risk of contamination or clotting.
Clinical Applications
These tubing sets are commonly used in outpatient dialysis centers and hospital dialysis units. They are essential in managing patients with chronic kidney disease requiring regular hemodialysis. Nephrologists and dialysis nurses use these devices to ensure effective treatment for patients with end-stage renal disease, facilitating the removal of waste products and excess fluid from the blood.
Indications for Use
The Sansin Tubing Sets are indicated for use in patients undergoing hemodialysis, a procedure necessary for individuals with significant kidney dysfunction. They are suitable for adult and pediatric patients who require dialysis to manage their kidney failure.
Practical Considerations
Sansin Tubing Sets are available in various lengths and configurations to accommodate different patient sizes and dialysis machines. They are compatible with standard hemodialysis equipment and require careful handling to maintain sterility and prevent kinking during use.
Frequently Asked Questions
What is Sansin Tubing Sets for Hemodialysis used for?
They are used to connect a patient's blood circulation to a dialysis machine during hemodialysis.
What specialties typically use this device?
Nephrology and dialysis technicians commonly use these devices in clinical settings.
What are the FDA-cleared indications?
They are indicated for use in patients undergoing hemodialysis due to kidney failure.
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.