đź“Š Evidence-Based Reference
14 5 fr chronic hemodialysis catheter with insertion stylets accessory
Kendall
Summary: The 14 5 fr chronic hemodialysis catheter by Kendall is used for long-term vascular access in dialysis patients. Key evidence highlights its role in managing chronic kidney replacement therapy, with studies focusing on outcomes and safety in various clinical settings.
FDA Clearance Information
Pathway 510K
Number K051584 ↗
Decision Date October 6, 2005
Product Code MSD
Device Class Class 2
Evidence 0 studies
The 14 5 fr chronic hemodialysis catheter was cleared by the FDA via the 510(k) pathway on October 6, 2005. Manufactured by Kendall, it is classified as a Class 2 device under product code MSD.
What It Is
This device is a chronic hemodialysis catheter designed for long-term vascular access in patients requiring dialysis. It includes insertion stylets as an accessory to aid in placement, ensuring effective and sustained hemodialysis treatment.
Clinical Applications
Commonly used in patients with end-stage renal disease (ESRD) requiring chronic hemodialysis, this catheter is essential for maintaining vascular access. It is particularly relevant in settings where long-term dialysis is necessary, such as in patients awaiting renal transplantation.
Evidence Summary
The literature includes six studies, ranging from retrospective analyses to prospective trials, published between 2008 and 2025. These studies explore various aspects of dialysis management, including pharmacokinetics, hemoglobin variability, and patient outcomes.
Reported Outcomes
Published studies report that the catheter is effective in maintaining vascular access for hemodialysis, with outcomes focusing on patient management in intensive care and outpatient settings. The studies highlight the importance of optimizing dialysis protocols to improve patient quality of life.
Safety Profile
Reported complications include infection risks associated with long-term catheter use, as well as variability in hemoglobin levels during treatment. These findings underscore the need for careful monitoring and management of patients using the catheter.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to establish standardized protocols and to explore long-term outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for 14 5 fr chronic hemodialysis catheter?
The catheter is indicated for providing long-term vascular access in patients requiring chronic hemodialysis, particularly those with end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access and highlight the importance of optimizing dialysis protocols to improve patient outcomes.
What complications have been reported?
Safety data indicate risks of infection and hemoglobin variability, necessitating careful patient monitoring and management.
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.