đź“‹ FDA Reference
bioteque a v fistula needle set
Bioteque
Summary: The Bioteque A V Fistula Needle Set is a medical device used primarily in dialysis procedures to access arteriovenous fistulas. It is utilized by nephrologists and dialysis nurses to facilitate efficient blood flow during hemodialysis.
FDA Clearance Information
Pathway
510K
Number
K993118 ↗
Decision Date
December 17, 1999
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Bioteque A V Fistula Needle Set was cleared by the FDA via the 510k pathway on December 17, 1999. It is manufactured by Bioteque and classified as a Class 2 device under product code FIE.
What It Is
The Bioteque A V Fistula Needle Set is designed for use in hemodialysis, providing a means to access the bloodstream through an arteriovenous fistula. The needle set typically includes a sharp needle attached to tubing, allowing for efficient blood withdrawal and return. Its design ensures minimal discomfort and maximizes blood flow efficiency, which is critical for effective dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by healthcare professionals specializing in nephrology and dialysis. It is essential for patients with chronic kidney disease who require regular hemodialysis. The needle set is used to establish a reliable and safe vascular access, which is crucial for the dialysis process.
Indications for Use
The FDA indications for the Bioteque A V Fistula Needle Set include its use in accessing arteriovenous fistulas for hemodialysis. It is intended for patients who require regular dialysis treatments due to kidney failure or other renal conditions.
Practical Considerations
The needle set comes in various sizes to accommodate different patient anatomies and fistula characteristics. Compatibility with standard dialysis machines and tubing systems is typically ensured. Proper technique in needle insertion and securement is vital to prevent complications such as infiltration or hematoma.
Frequently Asked Questions
What is Bioteque 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?
The device is indicated for use in accessing arteriovenous fistulas for hemodialysis in patients with renal conditions.
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.