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renax a v fistula needle sets
Sunder Biomedical Tech.
Summary: The Renax AV Fistula Needle Sets are used in hemodialysis to access arteriovenous fistulas. They are primarily utilized by nephrologists and dialysis nurses in outpatient dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K003123 ↗
Decision Date
May 4, 2001
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Renax AV Fistula Needle Sets were cleared through the FDA 510(k) pathway on May 4, 2001. Manufactured by Sunder Biomedical Tech., this device is classified as Class 2 under product code FIE.
What It Is
The Renax AV Fistula Needle Sets are medical devices designed for vascular access in patients undergoing hemodialysis. These needle sets facilitate the connection between the patient's arteriovenous fistula and the dialysis machine, allowing for efficient blood filtration. The device typically includes a sharp needle, tubing, and a connector to ensure secure and effective blood flow during dialysis sessions.
Clinical Applications
These needle sets are commonly used in dialysis centers where patients with chronic kidney disease receive regular hemodialysis treatments. Nephrologists and dialysis nurses use them to establish vascular access in patients with mature arteriovenous fistulas. The device is crucial for patients who require long-term dialysis, ensuring that the procedure is performed safely and efficiently.
Indications for Use
The FDA indications for the Renax AV Fistula Needle Sets include use in patients requiring vascular access for hemodialysis. This typically involves individuals with end-stage renal disease who have an established arteriovenous fistula.
Practical Considerations
The Renax AV Fistula Needle Sets come in various sizes to accommodate different patient needs and fistula characteristics. Compatibility with standard dialysis machines is ensured, and proper technique in needle insertion is crucial to minimize complications such as infiltration or hematoma.
Frequently Asked Questions
What is Renax AV Fistula Needle Sets used for?
They are used for vascular access in hemodialysis, connecting the patient's arteriovenous fistula to the dialysis machine.
What specialties typically use this device?
Nephrology and dialysis nursing specialties typically use this device in dialysis centers.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring vascular access for hemodialysis, particularly those with arteriovenous fistulas.
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.