đź“‹ FDA Reference
Pallindrome 14 5Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip
Kendall
Summary: The Palindrome 14 5Fr Chronic Hemodialysis Catheter is a vascular access device used for hemodialysis in patients with chronic kidney disease. It is typically used by nephrologists and dialysis nurses in hospital or outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K043272 ↗
Decision Date ?
December 22, 2004
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Palindrome 14 5Fr Chronic Hemodialysis Catheter, manufactured by Kendall, received FDA clearance via the 510(k) pathway on December 22, 2004. It is classified as a Class 2 device under product code MSD.
What It Is
The Palindrome 14 5Fr Chronic Hemodialysis Catheter is a specialized catheter designed for long-term hemodialysis access. It features a slotted symmetrical tip, which helps minimize recirculation and improve dialysis efficiency. The catheter is inserted into a central vein, typically the internal jugular or subclavian vein, providing a reliable conduit for blood to be removed, filtered, and returned during dialysis sessions.
FDA-Cleared Indications
- Provide vascular access for chronic hemodialysis.
- Use in patients with kidney failure who require hemodialysis.
Clinical Applications
- Vascular access for repeated hemodialysis treatments.
- Long-term central venous access when an arteriovenous fistula or graft is not available or cannot be used.
- Hemodialysis access in hospital or outpatient dialysis settings.
Practical Considerations
- The catheter is identified as 14 French with a slotted symmetrical tip; the available catheter length and lumen specifications should be confirmed from the current device labeling.
- Placement is generally performed into a central vein, most commonly the internal jugular vein, using sterile technique and image guidance when appropriate.
- The catheter must be compatible with the dialysis machine, blood-flow requirements, locking solution, and institutional dialysis protocols.
- Important risks include catheter-related bloodstream infection, thrombosis, bleeding, venous stenosis, malposition, and inadequate dialysis flow.
- MRI safety should be confirmed in the current manufacturer labeling for the exact catheter model and configuration; do not assume that an implanted dialysis catheter is universally MRI safe.
Frequently Asked Questions
What is the Palindrome 14 5Fr Chronic Hemodialysis Catheter used for?
It is used to provide vascular access for hemodialysis in patients with chronic kidney disease.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device in dialysis centers and hospitals.
What are the FDA-cleared indications?
The catheter is indicated for providing 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.