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hospal fistula needle
Hospal Medical
Summary: The Hospal Fistula Needle is a medical device used in hemodialysis to access the bloodstream through an arteriovenous fistula. It is primarily used by nephrologists and dialysis nurses in dialysis centers.
FDA Clearance Information
Pathway
510K
Number
K851453 ↗
Decision Date
April 29, 1985
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Hospal Fistula Needle was cleared through the FDA 510k pathway on April 29, 1985. It is manufactured by Hospal Medical and classified as a Class 2 device under product code FIE.
What It Is
The Hospal Fistula Needle is a specialized needle designed for accessing arteriovenous fistulas in patients undergoing hemodialysis. It facilitates the efficient transfer of blood to and from the dialysis machine. The device is engineered to minimize discomfort and reduce the risk of complications during dialysis sessions.
Clinical Applications
This device is commonly used in dialysis centers for patients with chronic kidney disease requiring hemodialysis. Nephrologists and dialysis nurses use it to establish vascular access through arteriovenous fistulas. It is crucial for maintaining effective dialysis treatment and ensuring adequate blood flow during the procedure.
Indications for Use
The FDA indications for the Hospal Fistula Needle include its use in patients who need vascular access for hemodialysis. It is intended for those with established arteriovenous fistulas or grafts, typically in chronic kidney disease or end-stage renal disease patients.
Practical Considerations
The Hospal Fistula Needle is available in various sizes to accommodate different patient anatomies and fistula characteristics. It is compatible with standard dialysis machines and requires proper technique to ensure effective and safe access. Clinicians should be trained in its use to minimize complications.
Related Literature
The linked study explored the estimation of blood access flow rates using dialysate urea measurements during hemodialysis. It demonstrated that blood flow rates can be accurately calculated using urea concentration changes when needles are reversed. This method offers a non-invasive way to monitor fistula function, though it may be limited by the need for specific equipment and conditions.
Frequently Asked Questions
What is the Hospal Fistula Needle used for?
It is used to access the bloodstream through an arteriovenous fistula for hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses in dialysis centers use this device.
What are the FDA-cleared indications?
It is indicated for use in patients needing vascular access for hemodialysis, specifically those with arteriovenous fistulas or grafts.
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.