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palindrome emerald 14 5 fr chronic hemodialysis catheter with heparin coating
Tyco Healthcare Group
Summary: The Palindrome Emerald 14.5 Fr Catheter is a hemodialysis catheter with heparin coating, used for chronic dialysis access. It is primarily used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway 510K
Number K060509 ↗
Decision Date June 23, 2006
Product Code NYU
Device Class Class 2
Evidence 7 studies
The Palindrome Emerald 14.5 Fr Catheter, manufactured by Tyco Healthcare Group, received FDA clearance via the 510k pathway on June 23, 2006. It is classified as a Class 2 device under product code NYU.
What It Is
The Palindrome Emerald 14.5 Fr Catheter is a chronic hemodialysis catheter designed for long-term vascular access in patients requiring dialysis. It features a heparin coating to reduce the risk of clotting and maintain patency. The catheter is inserted into a large central vein, typically the internal jugular or subclavian vein, allowing for efficient blood flow during dialysis sessions.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically placed by nephrologists or interventional radiologists in hospital or outpatient settings. The device is suitable for adult patients who need reliable and durable vascular access for chronic dialysis treatment.
Indications for Use
The FDA-cleared indications for this catheter include providing long-term vascular access for patients undergoing chronic hemodialysis. It is intended for use in patients who require regular dialysis due to kidney failure.
Practical Considerations
The Palindrome Emerald catheter is typically available in a 14.5 French size, which is suitable for adult patients. It is important to ensure proper placement and securement to minimize the risk of infection and dislodgement. Compatibility with dialysis machines and anticoagulation protocols should be confirmed prior to use.
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 Emerald 14.5 Fr Catheter used for?
The catheter is used for providing long-term vascular access in patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device in dialysis and vascular access procedures.
What are the FDA-cleared indications?
The catheter is indicated for providing long-term vascular access for chronic hemodialysis in patients with kidney failure.
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.