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hemosplit long-term hemodialysis catheter
C.R. Bard
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
510K
Number
K030020 ↗
Decision Date
June 16, 2003
Product Code
MSD
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.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require long-term hemodialysis but lack suitable arteriovenous fistulas or grafts. It is typically placed by nephrologists or interventional radiologists in hospital settings or dialysis centers. The device is suitable for adult and pediatric patients requiring chronic dialysis access.
Indications for Use
The HemoSplit catheter is indicated for patients needing long-term hemodialysis access. It is particularly useful for those who cannot have or are waiting for arteriovenous fistulas or grafts.
Practical Considerations
The HemoSplit catheter is available in various lengths to accommodate different patient anatomies. It is compatible with standard hemodialysis equipment. Proper technique during insertion and maintenance is crucial to minimize complications such as infection or thrombosis.
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.