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Symetrex Long Term Hemodialysis Catheter
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 ?
510(k)
Number ?
K140884 ↗
Decision Date ?
November 26, 2014
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients who require long-term dialysis access.
- Use in patients with chronic kidney disease or end-stage renal disease who need hemodialysis.
- Use when an arteriovenous fistula or graft is not available, suitable, or cannot be placed.
Clinical Applications
- Long-term central venous access for repeated hemodialysis treatments.
- Blood withdrawal from and return to the circulation during hemodialysis.
- Tunneled catheter placement through a central vein, commonly the internal jugular vein, when durable dialysis access is needed.
- Hemodialysis access for patients who are not candidates for an arteriovenous fistula or graft.
Practical Considerations
- The catheter is intended for use with standard hemodialysis equipment and must be selected in a size and configuration appropriate for the patient's anatomy and prescribed blood-flow requirements.
- Placement is generally performed using sterile technique and imaging guidance, with the catheter tip positioned in a suitable central vein or the cavoatrial region according to clinical practice and labeling.
- Potential complications include infection, catheter thrombosis or dysfunction, bleeding, venous stenosis, air embolism, arterial or vascular injury, and malposition.
- The product labeling and manufacturer instructions should be reviewed for MRI conditions, flushing protocols, locking solutions, material compatibility, and contraindications; MRI safety should not be assumed without specific labeling.
- A tunneled dialysis catheter is generally used when fistula or graft access is unavailable or unsuitable, because arteriovenous fistulas and grafts may provide longer-term access with fewer catheter-related infection risks.
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.