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 510K
Decision Date February 20, 2004
Product Code MSD
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.

Clinical Applications

This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically employed in hospital settings, dialysis centers, and sometimes in home dialysis setups. Nephrologists and dialysis nurses are the primary users, ensuring proper placement and maintenance to minimize infection risks and ensure effective dialysis.

Indications for Use

The catheter is indicated for patients with chronic kidney disease needing long-term hemodialysis. It is suitable for those who do not have a functioning arteriovenous fistula or graft, providing a temporary or semi-permanent solution for vascular access.

Practical Considerations

The Palindrome catheter is available in various lengths to accommodate different patient anatomies and insertion sites. It is compatible with standard dialysis equipment and requires careful insertion technique to avoid complications. Regular monitoring and maintenance are essential to prevent infection and ensure patency.

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 →
ClinicalTrials.gov

Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters

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.

📬 Stay Updated

Get the latest vascular education content delivered to your inbox.