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medisystems hemodialysis fistula set
Medisystems
Summary: The Medisystems Hemodialysis Fistula Set is a medical device used for vascular access in hemodialysis. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood filtration in patients with renal failure.
FDA Clearance Information
Pathway
510K
Number
K910734 ↗
Decision Date
June 20, 1991
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Medisystems Hemodialysis Fistula Set was cleared through the FDA 510(k) pathway on June 20, 1991. Manufactured by Medisystems, it is classified as a Class 2 device under product code FIE.
What It Is
The Medisystems Hemodialysis Fistula Set is designed to provide reliable vascular access for patients undergoing hemodialysis. It typically includes needles and tubing that connect the patient’s circulatory system to the dialysis machine. This setup allows for the efficient removal and return of blood during the dialysis process, which is crucial for patients with end-stage renal disease.
Clinical Applications
This device is commonly used in dialysis centers and hospitals by nephrologists and dialysis nurses. It is essential for patients with chronic kidney disease who require regular hemodialysis sessions. The fistula set is used in procedures where a vascular access point is needed, typically in the forearm, to facilitate the dialysis process.
Indications for Use
The FDA indications for the Medisystems Hemodialysis Fistula Set include use in patients who require hemodialysis due to renal failure. It is specifically designed for creating a vascular access point, which is a critical component of the dialysis treatment process.
Practical Considerations
Clinicians should consider the appropriate needle size and tubing length to match the patient's vascular anatomy and dialysis machine compatibility. Proper technique in needle insertion and maintenance of the access site is crucial to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the Medisystems Hemodialysis Fistula Set used for?
It is used to establish vascular access in patients undergoing hemodialysis, allowing for efficient blood filtration.
What specialties typically use this device?
Nephrologists and dialysis nurses in dialysis centers and hospitals primarily use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring hemodialysis due to renal failure, providing a means for vascular access.
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.