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symetrex long term hemodialysis catheter
Medcomp (Dba Medical Components, Inc.)
Summary: The Symetrex Long Term Hemodialysis Catheter is a medical device used for facilitating hemodialysis in patients with chronic kidney disease. It is typically used by nephrologists in dialysis centers or hospitals.
FDA Clearance Information
Pathway
510K
Number
K171618 ↗
Decision Date
November 16, 2017
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Symetrex Long Term Hemodialysis Catheter was cleared through the FDA's 510k pathway on November 16, 2017. It is manufactured by Medcomp and is classified as a Class 2 device under product code MSD.
What It Is
The Symetrex Long Term Hemodialysis Catheter is a vascular access device designed for long-term use in patients requiring hemodialysis. It is inserted into a large central vein, typically the internal jugular or subclavian vein, to provide reliable access to the bloodstream for dialysis treatments. The catheter is constructed to minimize infection risk and ensure efficient blood flow, which is critical for effective dialysis.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. Nephrologists and dialysis nurses typically manage its use in outpatient dialysis centers or hospital settings. It is particularly useful in patients who do not have a functional arteriovenous fistula or graft, or when immediate dialysis access is necessary.
Indications for Use
The FDA indications for the Symetrex catheter include providing vascular access for hemodialysis in patients with chronic kidney disease. It is intended for long-term use, meaning it can remain in place for extended periods, typically weeks to months, depending on the patient's needs and condition.
Practical Considerations
The Symetrex catheter comes in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis equipment and requires careful insertion technique to minimize complications such as infection or thrombosis. Regular monitoring and maintenance are essential to ensure its functionality and longevity.
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 nurses typically use this device in dialysis centers and hospital settings.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for hemodialysis in patients with chronic kidney disease, intended for long-term use.
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.