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aplan a v fistula needle set
Aplan Well Enterprise
Summary: The Aplan A V Fistula Needle Set is a medical device used in dialysis procedures to access arteriovenous fistulas. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K112734 ↗
Decision Date
April 24, 2012
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Aplan A V Fistula Needle Set was cleared by the FDA through the 510(k) pathway on April 24, 2012. Manufactured by Aplan Well Enterprise, it is classified as a Class 2 device under product code FIE.
What It Is
The Aplan A V Fistula Needle Set is designed for use in hemodialysis, providing a reliable means of accessing a patient's arteriovenous fistula. This device typically includes a needle, tubing, and connectors that facilitate the connection to dialysis machines. It is engineered to ensure smooth insertion and minimize trauma to the fistula site, which is crucial for maintaining long-term vascular access.
Clinical Applications
This device is commonly used in dialysis centers and hospitals during hemodialysis sessions. Nephrologists and dialysis nurses use it to establish vascular access in patients with chronic kidney disease requiring regular dialysis. The needle set is essential for patients with mature arteriovenous fistulas, ensuring efficient blood flow and effective dialysis treatment.
Indications for Use
The FDA-cleared indications for this device include use in patients who require vascular access for hemodialysis. It is specifically intended for those with an established arteriovenous fistula, a common access point for long-term dialysis treatment.
Practical Considerations
When using the Aplan A V Fistula Needle Set, clinicians should consider the needle gauge and length to match the patient's vascular anatomy and the dialysis machine's requirements. Compatibility with standard dialysis equipment is generally ensured, but confirming fit and function before use is advisable.
Frequently Asked Questions
What is Aplan A V Fistula Needle Set used for?
It is used for accessing arteriovenous fistulas in patients undergoing hemodialysis.
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 use in patients requiring vascular access for hemodialysis, specifically those 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.