📋 FDA Reference
Hemosplit Long-Term Hemodialysis Catheter
Summary: The HemoSplit Long-Term Hemodialysis Catheter is a device used for vascular access in patients requiring hemodialysis. It is primarily used by nephrologists in dialysis centers and hospitals.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K030020 ↗
Decision Date ?
June 16, 2003
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The HemoSplit catheter was cleared through the FDA 510(k) pathway on June 16, 2003. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code MSD.
What It Is
The HemoSplit Long-Term Hemodialysis Catheter is a tunneled venous catheter designed for long-term vascular access in patients undergoing hemodialysis. It features a split-tip design that facilitates efficient blood flow and minimizes the risk of clotting. The catheter is inserted into a central vein, typically the internal jugular, and tunneled under the skin to reduce infection risk.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients with renal failure.
- Hemodialysis access when an arteriovenous fistula or graft is not available, is unsuitable, or is still maturing.
Clinical Applications
- Providing chronic hemodialysis access through a tunneled central venous catheter.
- Connecting a patient to standard hemodialysis equipment for blood withdrawal and return.
- Providing dialysis access for patients awaiting creation or maturation of an arteriovenous fistula or graft.
Practical Considerations
- The catheter is available in different lengths to accommodate patient anatomy and the selected venous access route.
- It is generally placed under imaging guidance, commonly through the internal jugular vein, and tunneled beneath the skin before exiting on the chest.
- The catheter is compatible with standard hemodialysis equipment; dialysis staff must follow the device instructions for connection, flushing, locking, and dressing care.
- MRI safety depends on the exact catheter components and any accessories used. The product-specific labeling should be reviewed before MRI.
- Potential complications include infection, catheter dysfunction, thrombosis, malposition, bleeding, and central venous stenosis. It should not be used when the catheter or insertion procedure is contraindicated for the individual patient.
Related Literature
The linked study audited the survival of 812 tunneled venous catheters, including the HemoSplit, over six years. It found that catheter survival is influenced by factors such as catheter type and patient characteristics. The study highlighted the importance of catheter design in long-term use but was limited by its observational nature and single-institution setting.
Frequently Asked Questions
What is the HemoSplit Long-Term Hemodialysis Catheter used for?
It is used to provide long-term vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
It is indicated for patients requiring long-term hemodialysis access, especially those without suitable arteriovenous fistulas or grafts.
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.