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terumo av fistula needle set
Terumo Medical
Summary: The Terumo AV Fistula Needle Set is used for vascular access in hemodialysis. It is typically used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis sessions.
FDA Clearance Information
Pathway
510K
Number
K891062 ↗
Decision Date
June 22, 1989
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Terumo AV Fistula Needle Set was cleared through the FDA 510(k) pathway on June 22, 1989. It is manufactured by Terumo Medical and classified as a Class 2 device under product code FIE.
What It Is
The Terumo AV Fistula Needle Set is a medical device designed for creating vascular access in patients undergoing hemodialysis. It consists of a needle, tubing, and connectors that facilitate the connection between the patient's arteriovenous fistula and the dialysis machine. The device is engineered to ensure smooth blood flow and minimize trauma to the vessel walls.
Clinical Applications
This device is primarily used in dialysis centers and hospitals for patients with chronic kidney disease requiring regular hemodialysis. Nephrologists and dialysis nurses use it to access the patient's blood circulation through an arteriovenous fistula, a surgically created connection between an artery and a vein. It is essential for maintaining effective dialysis treatment and is used in both adult and pediatric populations.
Indications for Use
The Terumo AV Fistula Needle Set is indicated for use in patients who require vascular access for hemodialysis. It is specifically designed for those with an arteriovenous fistula, which is a common access point for dialysis treatment.
Practical Considerations
The needle set typically comes in various sizes to accommodate different patient needs and fistula characteristics. Compatibility with standard dialysis machines is ensured, and proper technique is crucial to minimize complications such as infiltration or hematoma.
Related Literature
The linked study compares the success rate of the distal radial approach versus the traditional radial approach in patients with STEMI. Although specific details and findings are not available, such studies generally aim to optimize vascular access techniques. Limitations include the lack of detailed findings and applicability to the specific use of the AV fistula needle set.
Frequently Asked Questions
What is the Terumo AV Fistula Needle Set used for?
It is used to provide vascular access for hemodialysis in patients with an arteriovenous fistula.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for vascular access in hemodialysis patients with an arteriovenous fistula.
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.