đź“‹ FDA Reference
symetrex long term hemodialysis catheter
Phase One Medical
Summary: The Symetrex Long Term Hemodialysis Catheter is a medical device used for providing vascular access for hemodialysis in patients with chronic kidney disease. It is primarily used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway
510K
Number
K140884 ↗
Decision Date
November 26, 2014
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Symetrex Long Term Hemodialysis Catheter was cleared through the FDA 510k pathway on November 26, 2014. It is manufactured by Phase One Medical and classified as a Class 2 device under product code MSD.
What It Is
The Symetrex Long Term Hemodialysis Catheter is a specialized catheter designed for long-term vascular access in patients requiring hemodialysis. It is typically inserted into a large vein, such as the internal jugular or subclavian vein, to facilitate efficient blood flow during dialysis sessions. The catheter is constructed to minimize complications such as infection and thrombosis, providing a reliable option for patients with chronic kidney disease.
Clinical Applications
This catheter is commonly used in nephrology and dialysis centers for patients who require ongoing hemodialysis treatment. It is suitable for patients with end-stage renal disease who need a durable and reliable vascular access solution. The device is often utilized in both inpatient and outpatient settings, catering to adult and pediatric populations who are unable to undergo arteriovenous fistula or graft placement.
Indications for Use
The Symetrex Long Term Hemodialysis Catheter is indicated for patients who require long-term hemodialysis access due to chronic kidney disease. It is particularly useful for those who are not candidates for other forms of vascular access.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard hemodialysis equipment. Proper insertion technique is crucial to minimize the risk of complications, and clinicians should be trained in catheter placement and maintenance.
Frequently Asked Questions
What is the Symetrex Long Term Hemodialysis Catheter used for?
It is used to provide long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and dialysis specialists typically use this device in both inpatient and outpatient settings.
What are the FDA-cleared indications?
The catheter is indicated for long-term hemodialysis access in patients with chronic kidney disease who require ongoing dialysis treatment.
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.