📋 FDA Reference
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
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 ?
510(k)
Number ?
K173667 ↗
Decision Date ?
May 17, 2018
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients with chronic kidney disease who require hemodialysis.
Clinical Applications
- Providing access for repeated hemodialysis treatments.
- Use when a patient requires long-term dialysis access and an arteriovenous fistula or graft is unavailable or not usable.
- Placement as a tunneled central venous dialysis catheter in an appropriate large vein.
Practical Considerations
- Available catheter lengths include 19, 23, 28, 33, and 37 cm; the appropriate length depends on the access vein, patient anatomy, and intended catheter-tip position.
- Placement and removal require sterile technique and imaging guidance by appropriately trained clinicians.
- The catheter must be connected only to compatible dialysis equipment and handled according to the manufacturer's instructions.
- Potential complications include infection, thrombosis, bleeding, catheter malposition, venous stenosis, air embolism, and inadequate blood flow.
- MRI safety and conditions should be confirmed in the current device labeling before an MRI examination; do not assume the catheter is MR safe or MR conditional without verification.
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.