đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients with renal failure.
- Temporary or semi-permanent bloodstream access when dialysis is required.
Clinical Applications
- Providing vascular access for hemodialysis.
- Supporting dialysis in patients who do not have a usable arteriovenous fistula or graft.
- Providing dialysis access in hospital or outpatient dialysis settings when central venous access is clinically required.
Practical Considerations
- Catheter length and diameter should be selected for the patient’s anatomy, access site and dialysis requirements.
- Common access sites include the internal jugular, subclavian or femoral vein; placement and position should be confirmed according to institutional practice.
- Strict sterile technique, securement and catheter-site care are important because bloodstream infection and thrombosis are recognized risks of dialysis catheters.
- The catheter should be connected only to compatible dialysis tubing, connectors and equipment specified by the manufacturer.
- MRI safety depends on the exact catheter model and its labeling; verify the device-specific MRI conditions before scanning.
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.