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argon dual lumen hemodialysis catheter
Argon Medical
Summary: The Argon dual lumen hemodialysis catheter is a medical device used for vascular access in hemodialysis. It is primarily used by nephrologists and dialysis nurses to facilitate the removal and return of blood during dialysis treatment.
FDA Clearance Information
Pathway
510K
Number
K842039 ↗
Decision Date
January 29, 1985
Product Code
KNZ
Device Class
Class 2
Evidence
0 studies
The Argon dual lumen hemodialysis catheter was cleared via the FDA 510(k) pathway on January 29, 1985. It is manufactured by Argon Medical and classified as a Class 2 medical device under product code KNZ.
What It Is
The Argon dual lumen hemodialysis catheter is a specialized tube designed for insertion into a large vein, typically in the neck, chest, or groin. It features two lumens, allowing for simultaneous removal and return of blood during hemodialysis. This design optimizes the efficiency of dialysis sessions by providing reliable vascular access.
Clinical Applications
This catheter is commonly used in patients with chronic kidney disease requiring hemodialysis. It is typically utilized in hospital settings, dialysis centers, and sometimes in home care environments. Nephrologists and dialysis nurses employ this device to ensure effective and efficient dialysis treatment, particularly in patients who do not have a functioning arteriovenous fistula or graft.
Indications for Use
The FDA indications for this device include providing vascular access for hemodialysis in patients with renal failure. It is intended for use in patients who require temporary or semi-permanent access to the bloodstream for dialysis.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and clinical needs. It is important to ensure proper placement and securement to minimize the risk of infection and ensure optimal function. Compatibility with standard dialysis machines and connectors is typically expected.
Frequently Asked Questions
What is the Argon dual lumen hemodialysis catheter used for?
It is used for providing vascular access in patients undergoing hemodialysis 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 catheter is indicated for vascular access in hemodialysis patients, particularly those needing temporary or semi-permanent 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.