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medisystems arterial-venous fistula needle set with securement device
Medisystems
Summary: The Medisystems Arterial-Venous Fistula Needle Set with Securement Device is used for vascular access in hemodialysis. It is primarily used by nephrologists and dialysis nurses in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K062953 ↗
Decision Date
February 12, 2007
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on February 12, 2007. It is manufactured by Medisystems and classified as a Class 2 device under product code FIE.
What It Is
The Medisystems Arterial-Venous Fistula Needle Set is designed for creating vascular access in patients undergoing hemodialysis. It includes a securement device to ensure stability and reduce the risk of dislodgement during treatment. The needle set facilitates the efficient transfer of blood between the patient and the dialysis machine, which is crucial for the dialysis process.
Clinical Applications
This device is commonly used in dialysis centers and hospitals where hemodialysis is performed. It is essential for patients with chronic kidney disease requiring regular dialysis sessions. Nephrologists and dialysis nurses use this needle set to establish reliable vascular access, which is critical for effective dialysis treatment.
Indications for Use
The device is indicated for use in patients requiring vascular access for hemodialysis, typically those with end-stage renal disease. It is used to connect the patient's circulatory system to the dialysis machine.
Practical Considerations
The needle set comes in various sizes to accommodate different patient anatomies and fistula types. It is compatible with standard dialysis equipment. Proper technique is essential to minimize complications such as infiltration or hematoma formation.
Frequently Asked Questions
What is the Medisystems Arterial-Venous Fistula Needle Set used for?
It is used to establish vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for creating vascular access for hemodialysis in patients 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.