đź“‹ FDA Reference
Palindrome 14 5 Fr Chronic Hemodialysis Catheter
Kendall
Summary: The Palindrome 14 5 Fr Chronic Hemodialysis Catheter is a vascular access device used for hemodialysis in patients with chronic kidney disease. It is primarily used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K033676 ↗
Decision Date ?
February 20, 2004
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
7 studies
The Palindrome 14 5 Fr Chronic Hemodialysis Catheter was cleared through the FDA 510(k) pathway on February 20, 2004. Manufactured by Kendall, it is classified as a Class 2 device under product code MSD.
What It Is
The Palindrome 14 5 Fr Chronic Hemodialysis Catheter is a specialized vascular access device designed for long-term hemodialysis. It features a dual-lumen design that facilitates efficient blood flow and dialysis treatment. The catheter is typically inserted into a central vein, such as the internal jugular or subclavian vein, providing a reliable access point for repeated dialysis sessions.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients with chronic kidney disease.
- Use as an implanted hemodialysis catheter when repeated access to the bloodstream is required.
Clinical Applications
- Providing blood access for chronic hemodialysis treatments.
- Placement in a central vein, commonly the internal jugular vein, for repeated dialysis access.
- Use in patients who do not have a usable arteriovenous fistula or graft.
- Connection to standard hemodialysis equipment through separate arterial and venous catheter lumens.
Practical Considerations
- The catheter is a dual-lumen device; one lumen removes blood for dialysis and the other returns filtered blood.
- Available catheter length and configuration should match the patient's anatomy and intended central venous access site.
- Placement generally uses ultrasound and fluoroscopic or other imaging guidance, with local anesthesia and sedation as clinically appropriate.
- The catheter must be handled using sterile technique and requires regular assessment for infection, thrombosis, poor flow and mechanical complications.
- MRI safety and conditions depend on the specific catheter model and current manufacturer labeling; the exact product documentation should be checked before MRI.
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 Palindrome 14 5 Fr Chronic Hemodialysis Catheter used for?
It is used for providing vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and dialysis specialists typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The catheter is indicated for long-term hemodialysis in patients with chronic kidney disease who require vascular access.
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.