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 ?
510(k)
Number ?
K051584 ↗
Decision Date ?
October 6, 2005
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for chronic hemodialysis in patients who require ongoing dialysis.
- Placement in the central venous system to allow blood withdrawal and return during hemodialysis.
Clinical Applications
- Providing temporary or longer-term central venous access when hemodialysis is required.
- Connecting a patient to a hemodialysis circuit for removal and return of blood.
- Use in patients with chronic kidney failure who need dialysis access and do not have a usable arteriovenous fistula or graft.
- Placement using the supplied insertion stylets to assist with catheter insertion.
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.
Practical Considerations
- The listed catheter size is 14.5 French; catheter length and configuration should be selected for the intended venous access route and patient anatomy.
- The catheter is generally placed in a central vein, commonly the internal jugular vein, using sterile technique and imaging guidance when appropriate.
- Catheter tip position should be confirmed according to institutional practice before dialysis use.
- MRI safety depends on the specific catheter materials and labeling; review the manufacturer’s current instructions for use before MRI.
- Potential complications include infection, thrombosis, bleeding, venous stenosis, malposition, catheter dysfunction, air embolism and injury to nearby structures.
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.