đź“‹ FDA Reference
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 ?
510(k)
Number ?
K060509 ↗
Decision Date ?
June 23, 2006
Product Code ?
NYU Catheter, Hemodialysis, Implanted, Coated
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.
FDA-Cleared Indications
- Long-term vascular access for patients undergoing chronic hemodialysis.
- Use in patients who require regular hemodialysis because of kidney failure.
Clinical Applications
- Providing central venous access for repeated chronic hemodialysis treatments.
- Removing blood from the patient for dialysis and returning filtered blood through the catheter.
- Use as a tunneled dialysis access catheter when a patient requires durable access for ongoing hemodialysis.
Practical Considerations
- The listed catheter size is 14.5 French and is generally intended for adult chronic hemodialysis access.
- Placement requires imaging guidance and careful positioning, commonly through the internal jugular vein; the subclavian vein may also be used when clinically appropriate.
- The heparin coating is intended to help maintain catheter patency, but it does not eliminate the need for an appropriate anticoagulation and catheter-lock protocol.
- Compatibility with the dialysis machine, blood-flow requirements, catheter-lock solution and institutional protocols should be confirmed before use.
- MRI safety and conditions should be verified in the current manufacturer instructions for use; the presence of a heparin coating alone does not establish MRI safety.
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.