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tandem-cath hemodialysis catheter model 10 fr
Kendall
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
510K
Number
K041006 ↗
Decision Date
May 19, 2004
Product Code
MSD
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.
Clinical Applications
Commonly used in patients with end-stage renal disease requiring hemodialysis, the catheter provides reliable vascular access. It is suitable for both temporary and long-term dialysis needs.
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.
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.