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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 ?
510(k)
Number ?
K171618 ↗
Decision Date ?
November 16, 2017
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Provides vascular access for hemodialysis in patients with chronic kidney disease.
- Intended for long-term hemodialysis access.
Clinical Applications
- Long-term central venous access for repeated hemodialysis treatments.
- Hemodialysis access for patients who do not have a usable arteriovenous fistula or graft.
- Hemodialysis access when a catheter is needed while permanent dialysis access is created or becomes usable.
- Dialysis access managed in a hospital or outpatient dialysis setting.
Practical Considerations
- The catheter is placed into a large central vein, commonly the internal jugular vein; other access sites may be selected based on the patient's anatomy and clinical history.
- Placement typically uses ultrasound and fluoroscopic or other radiographic guidance, with local anesthesia and moderate sedation or another anesthesia plan when appropriate.
- The catheter must be connected to compatible dialysis equipment and handled using strict sterile technique to reduce infection and catheter dysfunction.
- Potential complications include infection, thrombosis, bleeding, vessel injury, malposition and inadequate blood flow.
- MRI safety depends on the specific catheter configuration and labeling; the exact product instructions should be reviewed before MRI.
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.