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deseret subclavian hemodialysis catheter
Deseret Medical
Summary: The Deseret Subclavian Hemodialysis Catheter is a medical device used for hemodialysis access. It is typically utilized by nephrologists and vascular specialists in patients requiring dialysis.
FDA Clearance Information
Pathway
510K
Number
K881695 ↗
Decision Date
June 23, 1988
Product Code
LFJ
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on June 23, 1988, by Deseret Medical. It is classified as a Class 2 device under product code LFJ.
What It Is
The Deseret Subclavian Hemodialysis Catheter is a specialized catheter designed for vascular access in hemodialysis patients. It is inserted into the subclavian vein, providing a reliable conduit for blood to be removed, filtered, and returned during dialysis sessions. This device is crucial for patients with chronic kidney disease who require regular dialysis treatments.
Clinical Applications
Commonly used in nephrology and vascular surgery, this catheter is indicated for patients with end-stage renal disease who need long-term dialysis access. It is typically placed in hospital or outpatient settings and is suited for adult and pediatric patients requiring regular hemodialysis. The device is often used when other forms of access, such as AV fistulas, are not feasible.
Indications for Use
The catheter is intended for patients requiring hemodialysis, particularly those with chronic kidney failure. It is used when long-term vascular access is needed, and other access methods are unsuitable or unavailable.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and needs. It is compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the Deseret Subclavian Hemodialysis Catheter used for?
It is used for vascular access in patients requiring hemodialysis, particularly those with chronic kidney disease.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for hemodialysis in patients with chronic kidney failure.
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.