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supercath a v fistula
Togo Medikit
Summary: The Supercath A V Fistula is a medical device used for vascular access in hemodialysis patients. It is primarily used by nephrologists and dialysis nurses to facilitate efficient blood flow during dialysis treatments.
FDA Clearance Information
Pathway
510K
Number
K854773 ↗
Decision Date
April 8, 1986
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The Supercath A V Fistula was cleared through the FDA 510(k) pathway on April 8, 1986. Manufactured by Togo Medikit, it is classified as a Class 2 device under product code FIE.
What It Is
The Supercath A V Fistula is a specialized catheter designed for use in arteriovenous fistulas, which are surgically created connections between an artery and a vein. This device allows for repeated access to the bloodstream, which is essential for patients undergoing regular hemodialysis. Its design ensures durability and minimizes complications such as infection or clotting.
Clinical Applications
This device is commonly used in dialysis centers and hospitals, particularly in nephrology departments. It is essential for patients with end-stage renal disease who require regular hemodialysis. The device is used to establish and maintain vascular access, ensuring that blood can be efficiently removed, filtered, and returned to the patient during dialysis sessions.
Indications for Use
The Supercath A V Fistula is indicated for patients needing long-term vascular access for hemodialysis. It is specifically designed for those with arteriovenous fistulas, providing a reliable means of accessing the bloodstream for dialysis treatments.
Practical Considerations
When using the Supercath A V Fistula, clinicians should consider the appropriate size and length to match the patient's anatomy and the location of the fistula. Compatibility with other dialysis equipment is generally standard, but always verify with the manufacturer's guidelines. Proper technique in insertion and maintenance is crucial to prevent complications.
Frequently Asked Questions
What is Supercath A V Fistula used for?
It is used for vascular access in patients undergoing hemodialysis, allowing efficient blood flow during treatment.
What specialties typically use this device?
Nephrologists and dialysis nurses primarily use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring long-term vascular access for hemodialysis, specifically those with arteriovenous fistulas.
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.