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bioteque a v fistula needle set with safety flex
Bioteque
Summary: The Bioteque A V Fistula Needle Set with Safety Flex is used for vascular access in hemodialysis. It is primarily utilized by nephrologists and dialysis nurses to facilitate efficient and safe dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K032292 ↗
Decision Date
March 22, 2004
Product Code
FOZ
Device Class
Class 2
Evidence
0 studies
The Bioteque A V Fistula Needle Set with Safety Flex was cleared through the FDA 510(k) pathway on March 22, 2004. Manufactured by Bioteque, it is classified as a Class 2 device under product code FOZ.
What It Is
The Bioteque A V Fistula Needle Set with Safety Flex is a medical device designed for creating vascular access in patients undergoing hemodialysis. It features a safety mechanism to reduce the risk of needlestick injuries. The needle set is used to connect the patient's arteriovenous fistula to the dialysis machine, allowing for efficient blood filtration.
Clinical Applications
This device is commonly used in dialysis centers and hospitals for patients requiring regular hemodialysis. Nephrologists and dialysis nurses use it to ensure safe and effective vascular access. It is particularly important for patients with chronic kidney disease who need ongoing dialysis treatment.
Indications for Use
The FDA-cleared indications for this device include its use in establishing vascular access for hemodialysis. It is intended for patients with end-stage renal disease who require regular dialysis sessions.
Practical Considerations
The needle set typically comes in various sizes to accommodate different patient needs and fistula sizes. It is compatible with standard dialysis equipment, and clinicians should be trained in proper insertion techniques to minimize complications.
Frequently Asked Questions
What is the Bioteque A V Fistula Needle Set with Safety Flex used for?
It is used for vascular access in patients undergoing hemodialysis, facilitating the connection between the patient's fistula and the dialysis machine.
What specialties typically use this device?
Nephrology and dialysis nursing are the primary specialties that use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for establishing vascular access in patients requiring hemodialysis, particularly those with end-stage renal disease.
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.