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Tandem-Cath Hemodialysis Catheter Model 10 Fr
Kendall
Product: Tandem-Cath — all models and sizes
Summary: The tandem-cath hemodialysis catheter by Kendall is a device used for dialysis access. It is FDA 510k cleared and supported by 10 studies. Key findings highlight its role in effective dialysis access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K041006 ↗
Decision Date ?
May 19, 2004
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The tandem-cath hemodialysis catheter was cleared by the FDA through the 510k pathway on May 19, 2004. It is manufactured by Kendall and classified as a Class 2 device.
What It Is
The tandem-cath hemodialysis catheter is a 10 French catheter designed for vascular access in hemodialysis. It facilitates efficient blood flow for dialysis treatment, intended for patients requiring regular dialysis.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Use as an implanted hemodialysis catheter for patients requiring dialysis access.
Clinical Applications
- Providing central venous access for hemodialysis treatments.
- Connecting a patient to an extracorporeal dialysis circuit for removal of fluid and waste products.
- Use in patients who require hemodialysis access when a catheter-based access route is selected.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2022 and 2024. These studies evaluate catheter function, infection prevention, and insertion techniques.
Reported Outcomes
Published studies report that the tandem-cath hemodialysis catheter is effective in providing reliable vascular access for dialysis. Outcomes include improved catheter function and reduced incidence of bloodstream infections with specific lock solutions.
Safety Profile
Reported complications include catheter-related bloodstream infections, which are a significant concern in long-term use. Studies highlight the importance of infection prevention strategies.
Evidence Limitations
The evidence is limited by the small number of RCTs and the variability in study designs. Further research is needed to establish standardized protocols for catheter insertion and maintenance.
Practical Considerations
- The listed model is 10 French; catheter length and configuration should be confirmed from the device labeling before placement.
- Placement and use require sterile technique and imaging or other appropriate guidance according to institutional practice.
- The catheter should be used only with compatible dialysis equipment, connectors, anticoagulant or locking solutions, and accessories specified in the labeling.
- MRI safety status is not established by the information provided; review the current manufacturer labeling before an MRI examination.
- Potential complications of hemodialysis catheters include infection, thrombosis, bleeding, vessel injury, malposition, air embolism, and inadequate blood flow.
Frequently Asked Questions
What are the clinical indications for the tandem-cath hemodialysis catheter?
The catheter is indicated for vascular access in patients requiring hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective dialysis access and reduced infection rates with specific lock solutions.
What complications have been reported?
Complications include catheter-related bloodstream infections, emphasizing the need for infection control measures.
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.