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kedall 14 5 fr chronic hemodialysis catheter w silver impregnated sleeve palindrome ruby
Kendall
Summary: The Kendall 14 5 Fr Chronic Hemodialysis Catheter is used for long-term hemodialysis access. It is primarily used by nephrologists and vascular surgeons in patients requiring chronic dialysis.
FDA Clearance Information
Pathway
510K
Number
K060972 ↗
Decision Date
August 4, 2006
Product Code
MSD
Device Class
Class 2
Evidence
7 studies
The Kendall 14 5 Fr Chronic Hemodialysis Catheter was cleared through the FDA 510k pathway on August 4, 2006. It is manufactured by Kendall and is classified as a Class 2 device.
What It Is
This device is a chronic hemodialysis catheter designed for long-term vascular access in patients undergoing hemodialysis. It features a silver-impregnated sleeve to reduce infection risk. The catheter is inserted into a central vein, allowing for efficient blood flow during dialysis sessions.
Clinical Applications
The catheter is commonly used in nephrology and vascular surgery settings for patients with end-stage renal disease requiring regular hemodialysis. It is typically placed in a hospital or outpatient surgical center by a trained clinician. The device is suitable for adult patients who need reliable and long-term vascular access.
Indications for Use
The catheter is indicated for patients who require chronic hemodialysis, typically those with end-stage renal disease. It provides a stable and long-term solution for vascular access, essential for effective dialysis treatment.
Practical Considerations
The catheter is available in a 14 French size, which is common for adult hemodialysis patients. It is compatible with standard hemodialysis equipment and requires careful insertion and maintenance to minimize infection risk. Clinicians should be familiar with central venous catheterization techniques.
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 is the Kendall 14 5 Fr Chronic Hemodialysis Catheter used for?
It is used for providing long-term vascular access for patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device in the management of patients requiring chronic dialysis.
What are the FDA-cleared indications?
The device is indicated for patients requiring chronic hemodialysis, providing stable vascular access for dialysis treatments.
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.