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avf set for single needle hemodialysis
Terumo America
Summary: The AVF set for single needle hemodialysis by Terumo America is used for vascular access in hemodialysis patients. It is primarily utilized by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K772362 ↗
Decision Date
March 17, 1978
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The AVF set for single needle hemodialysis was cleared through the FDA 510k pathway on March 17, 1978. It is manufactured by Terumo America and classified as a Class 2 medical device.
What It Is
The AVF set for single needle hemodialysis is a medical device used to facilitate vascular access in patients undergoing hemodialysis. It allows for the efficient removal and return of blood during dialysis sessions through a single needle, reducing the number of punctures required. This device is particularly beneficial in patients with limited vascular access options.
Clinical Applications
This device is commonly used in outpatient dialysis centers and hospital settings where hemodialysis is performed. It is primarily used by nephrologists and dialysis nurses to manage patients with chronic kidney disease who require regular dialysis. The single needle approach is advantageous in patients with fragile veins or limited access sites.
Indications for Use
The AVF set is indicated for patients who need hemodialysis and have an arteriovenous fistula. It is suitable for those who may benefit from a single needle technique, such as patients with limited vascular access.
Practical Considerations
Clinicians should consider the appropriate needle size for the patient's vascular anatomy. Compatibility with existing dialysis machines should be verified. Proper technique in needle insertion and device handling is crucial to minimize complications.
Related Literature
The linked study, titled 'Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access,' explored the use of an endovascular approach for creating AVFs. The study found that this method could reduce complications associated with traditional surgical AVF creation. However, the study was limited by its sample size and the need for long-term outcome data.
Frequently Asked Questions
What is the AVF set for single needle hemodialysis used for?
It is used to provide vascular access for patients undergoing hemodialysis, allowing blood to be efficiently removed and returned through a single needle.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis with an arteriovenous fistula, particularly when a single needle technique is beneficial.
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.