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15 5f x 19 cm symetrex long term hemodialysis catheter with sideholes 15 5f x 23 cm symetrex long term hemodialysis catheter with sideholes 15 5f x 28 cm symetrex long term hemodialysis catheter with sideholes 15 5f x 33 cm symetrex long term hemodialysis catheter with sideholes 15 5f x 37 cm symetrex long term hemodialysis catheter with sideholes
Medical Components, Inc. (Dba Medcomp)
Summary: The Symetrex Long Term Hemodialysis Catheter is a device used for long-term hemodialysis access. It is primarily used by nephrologists and vascular surgeons for patients requiring dialysis.
FDA Clearance Information
Pathway
510K
Number
K173667 ↗
Decision Date
May 17, 2018
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Symetrex Long Term Hemodialysis Catheter by Medical Components, Inc. (Medcomp) was cleared via the FDA 510(k) pathway on May 17, 2018. It is a Class 2 medical device under product code MSD.
What It Is
The Symetrex Long Term Hemodialysis Catheter is a flexible tube designed for long-term vascular access in patients undergoing hemodialysis. It features sideholes to facilitate efficient blood flow during dialysis sessions. The catheter is inserted into a large vein, typically in the neck or chest, and provides a reliable conduit for blood to be removed, filtered, and returned to the patient's body.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically utilized in hospital settings, dialysis centers, or outpatient clinics. Nephrologists and vascular surgeons are the primary specialists involved in the placement and management of these catheters, which are critical for patients who do not have a functioning arteriovenous fistula or graft.
Indications for Use
The FDA indications for this device include providing long-term vascular access for hemodialysis in patients with chronic kidney disease. It is intended for patients who need ongoing dialysis treatment and do not have other viable access options.
Practical Considerations
The Symetrex catheter comes in various lengths (19 cm to 37 cm) to accommodate different patient anatomies and insertion sites. Proper sizing and placement technique are crucial for optimal function and minimizing complications. Compatibility with standard dialysis equipment should be verified before use.
Frequently Asked Questions
What is the Symetrex Long Term Hemodialysis Catheter used for?
It is used for providing long-term vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device for patients requiring hemodialysis.
What are the FDA-cleared indications?
The catheter is indicated for long-term vascular access for hemodialysis in patients with chronic kidney disease.
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.