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14 5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve Palindrome Sapphire
Kendall
Summary: The 14 5 Fr Chronic Hemodialysis Catheter by Kendall is designed for long-term hemodialysis access. Key evidence highlights its use in chronic kidney replacement therapy with a focus on infection management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K062671 ↗
Decision Date ?
November 3, 2006
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
7 studies
The device was cleared via the FDA 510(k) pathway on November 3, 2006. Manufactured by Kendall, it is classified as a Class 2 medical device under product code MSD.
What It Is
The 14 5 Fr Chronic Hemodialysis Catheter is a heparin-coated catheter with a silver-impregnated sleeve, designed to provide vascular access for chronic hemodialysis. It is intended for use in patients requiring long-term dialysis access.
FDA-Cleared Indications
- Vascular access for chronic hemodialysis.
- Use in patients requiring long-term hemodialysis access.
Clinical Applications
- Providing blood access for repeated hemodialysis treatments.
- Long-term dialysis access for patients with end-stage kidney disease.
- Use when chronic kidney replacement therapy requires a central venous catheter.
Evidence Summary
The available literature includes six studies, comprising retrospective analyses and case series, published between 2008 and 2025. These studies explore various aspects of dialysis treatment and catheter use.
Reported Outcomes
Published studies report that the catheter is effective in providing reliable vascular access for hemodialysis. Outcomes include successful management of infections with post-dialysis antibiotic therapy and variability in hemoglobin levels during treatment.
Safety Profile
Reported complications include infection risks associated with catheter use, as highlighted in studies focusing on antibiotic therapy post-dialysis. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence base is limited by the retrospective nature of many studies and a lack of large-scale randomized controlled trials. Further research is needed to optimize catheter use and improve patient outcomes.
Practical Considerations
- The catheter is identified as 14.5 French; the exact lumen configuration and catheter length should be confirmed from the applicable device labeling.
- Placement generally requires central venous access under imaging guidance, commonly through the internal jugular vein, with the catheter tip positioned in a central vein.
- The catheter is intended for hemodialysis and should be used only with compatible dialysis equipment and according to the manufacturer's instructions.
- Assess for infection, thrombosis, central venous stenosis, bleeding risk, and inadequate venous anatomy before placement.
- MRI compatibility, including conditions for scanning, should be confirmed in the current manufacturer labeling before an MRI examination.
Linked Studies (7)
PubMed • 2020
Comparison of Clinical Performance of VectorFlow and Palindrome Symmetric-Tip Dialysis Catheters: A Multicenter, Randomized Trial.
Journal of vascular and interventional radiology : JVIR
RCT View Source →PubMed • 2016
A retrospective study of palindrome symmetrical-tip catheters for chronic hemodialysis access in China.
Renal failure
View Source →PubMed • 2014
Clinical application of long-term Palindrome catheter in hemodialysis patients.
Iranian journal of kidney diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Comparison of the palindrome vs. step-tip tunneled hemodialysis catheter: a prospective randomized trial.
Seminars in dialysis
RCT|prospective View Source →PubMed • 2013
Computational flow dynamics and preclinical assessment of a novel hemodialysis catheter.
Seminars in dialysis
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2006
Comparison of recirculation percentage of the palindrome catheter and standard hemodialysis catheters in a swine model.
Journal of vascular and interventional radiology : JVIR
RCT|prospective|retrospective|case Series|other View Source →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 undergoing chronic hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective vascular access for hemodialysis and successful infection management with post-dialysis antibiotic therapy.
What complications have been reported?
Reported complications include infection risks associated with catheter use, as noted in studies on antibiotic therapy.
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.