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kawasumi a v fistula set
Kawasumi Laboratories
Summary: The Kawasumi A V Fistula Set is a medical device used for creating arteriovenous fistulas, primarily in patients requiring dialysis. It is typically used by vascular surgeons and nephrologists.
FDA Clearance Information
Pathway
510K
Number
K873421 ↗
Decision Date
October 9, 1987
Product Code
FKQ
Device Class
Class 2
Evidence
0 studies
The Kawasumi A V Fistula Set was cleared through the FDA 510(k) pathway on October 9, 1987. Manufactured by Kawasumi Laboratories, it is classified as a Class II device under product code FKQ.
What It Is
The Kawasumi A V Fistula Set is a specialized kit designed for the creation of arteriovenous (AV) fistulas, which are connections made between an artery and a vein. These fistulas are essential for patients undergoing hemodialysis, as they provide a reliable and durable access point for the procedure. The set typically includes needles, catheters, and other components necessary for the surgical creation of the fistula.
Clinical Applications
This device is commonly used in the surgical creation of AV fistulas for patients with end-stage renal disease who require regular hemodialysis. It is typically used in hospital settings or specialized dialysis centers by vascular surgeons or nephrologists. The device is crucial for ensuring patients have a stable and long-term access point for dialysis, reducing complications associated with other forms of vascular access.
Indications for Use
The FDA indications for the Kawasumi A V Fistula Set involve its use in creating arteriovenous fistulas for patients who need hemodialysis. It is specifically indicated for patients with chronic kidney disease who require a reliable vascular access for dialysis treatments.
Practical Considerations
When using the Kawasumi A V Fistula Set, clinicians should consider the typical sizing of the components to ensure compatibility with the patient's anatomy. Proper technique is crucial to minimize complications such as infection or thrombosis. The set is generally compatible with standard surgical procedures for AV fistula creation.
Frequently Asked Questions
What is the Kawasumi A V Fistula Set used for?
It is used for creating arteriovenous fistulas in patients requiring hemodialysis.
What specialties typically use this device?
Vascular surgeons and nephrologists commonly use this device in the context of dialysis access.
What are the FDA-cleared indications?
The device is indicated for creating arteriovenous fistulas in patients needing hemodialysis 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.