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pallindrome 14 5fr chronic hemodialysis catheter
Kendall
Summary: The Palindrome 14 5Fr Chronic Hemodialysis Catheter is a medical device used for chronic hemodialysis. It is typically used by nephrologists and dialysis nurses to provide vascular access for patients requiring long-term dialysis.
FDA Clearance Information
Pathway 510K
Number K041914 ↗
Decision Date September 27, 2004
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Palindrome 14 5Fr Chronic Hemodialysis Catheter was cleared through the FDA 510(k) pathway on September 27, 2004. Manufactured by Kendall, it is classified as a Class 2 device under product code MSD.
What It Is
The Palindrome 14 5Fr Chronic Hemodialysis Catheter is a dual-lumen catheter designed for long-term vascular access in patients undergoing hemodialysis. It facilitates the efficient removal and return of blood during dialysis sessions. The catheter's design aims to minimize complications such as thrombosis and infection, which are common concerns in chronic dialysis access.
Clinical Applications
This catheter is commonly used in nephrology settings, particularly in outpatient dialysis centers and hospitals. It is indicated for patients with end-stage renal disease who require ongoing hemodialysis. The device is suitable for adult patients and is typically inserted by interventional radiologists or vascular surgeons.
Indications for Use
The FDA-cleared indications for this catheter include providing vascular access for chronic hemodialysis in patients with kidney failure. It is intended for patients who need long-term dialysis treatment.
Practical Considerations
The Palindrome catheter is typically available in various lengths to accommodate different patient anatomies. It is compatible with standard hemodialysis equipment. Proper insertion technique is crucial to minimize risks of infection and ensure optimal function.
Frequently Asked Questions
What is the Palindrome 14 5Fr Chronic Hemodialysis Catheter used for?
It is used to provide long-term vascular access for patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists, interventional radiologists, and vascular surgeons typically use this device in dialysis settings.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for chronic hemodialysis in patients with end-stage renal disease.
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.