đź“‹ FDA Reference
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 ?
510(k)
Number ?
K060972 ↗
Decision Date ?
August 4, 2006
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for chronic hemodialysis.
- Long-term central venous access for blood withdrawal and return during hemodialysis treatments.
Clinical Applications
- Providing long-term vascular access for patients receiving chronic hemodialysis.
- Connecting a patient to standard hemodialysis equipment for blood removal, filtration and return.
- Use as a tunneled central venous catheter when chronic dialysis access is required.
Practical Considerations
- The listed catheter size is 14 French; the product name also includes 5 Fr, so clinicians should verify the specific catalog number, catheter diameter and configuration in the current labeling before use.
- Placement requires sterile central venous catheterization, typically with ultrasound and fluoroscopic or other imaging guidance, followed by confirmation of catheter position.
- The catheter must be compatible with the dialysis circuit and maintained according to the manufacturer's instructions to reduce infection, thrombosis and malfunction.
- The device's MRI conditions are not established by the supplied FDA record. Check current manufacturer labeling before an MRI examination.
- Contraindications and warnings include inability to safely access the target vein, local or systemic infection, thrombosis or stenosis involving the intended access route, and any patient-specific condition identified in the current labeling.
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.