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vital tubing sets for hemodialysis
Vital Healthcare Sdn. Bhd.
Summary: Vital tubing sets for hemodialysis are used in dialysis procedures to transport blood between the patient and the dialysis machine. They are primarily used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K251341 ↗
Decision Date
January 16, 2026
Product Code
FJK
Device Class
Class 2
Evidence
0 studies
The vital tubing sets for hemodialysis by Vital Healthcare Sdn. Bhd. were cleared via the FDA 510k pathway on January 16, 2026. This device is classified as Class 2 under product code FJK.
What It Is
The vital tubing sets for hemodialysis are medical devices designed to facilitate the transport of blood from a patient to a dialysis machine and back. They are composed of biocompatible materials to ensure patient safety and minimize the risk of infection. These tubing sets are essential components of the hemodialysis circuit, ensuring efficient blood flow and dialysis treatment.
Clinical Applications
These tubing sets are commonly used in hemodialysis centers and hospitals. They are essential for patients with chronic kidney disease requiring regular dialysis. Nephrologists and dialysis nurses utilize these devices to manage patients with end-stage renal disease. The tubing sets are crucial in both acute and chronic dialysis settings, ensuring effective blood purification.
Indications for Use
The FDA indications for these tubing sets include use in hemodialysis procedures for patients requiring renal replacement therapy. They are suitable for individuals with compromised kidney function who need regular dialysis to maintain homeostasis.
Practical Considerations
Vital tubing sets come in various lengths and diameters to accommodate different patient sizes and dialysis machines. They are designed for compatibility with standard dialysis equipment. Proper technique in connecting and securing the tubing is essential to prevent leaks and ensure patient safety.
Frequently Asked Questions
What is vital tubing sets for hemodialysis used for?
They are used to transport blood between the patient and the dialysis machine during hemodialysis procedures.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use these devices in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The tubing sets are indicated for use in hemodialysis procedures for patients requiring renal replacement therapy.
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.