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
510K
Number
K043272 ↗
Decision Date
December 22, 2004
Product Code
MSD
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.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically employed in settings such as dialysis centers, hospitals, and sometimes in home dialysis setups. Nephrologists and dialysis nurses are the primary users, managing the catheter's insertion, maintenance, and removal. It is particularly useful in patients who have exhausted other forms of vascular access or when immediate dialysis access is required.
Indications for Use
The FDA indications for this catheter include providing vascular access for chronic hemodialysis in patients with kidney failure. It is suitable for patients who need long-term dialysis treatment and have limited options for other types of vascular access.
Practical Considerations
The Palindrome catheter is available in a 14 French size, which is compatible with most dialysis machines and setups. Proper insertion technique is critical to minimize complications such as infection or thrombosis. Clinicians should ensure compatibility with the patient's vascular anatomy and consider ultrasound guidance for placement.
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.