đź“‹ FDA Reference
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 ?
510(k)
Number ?
K041914 ↗
Decision Date ?
September 27, 2004
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for chronic hemodialysis.
- Use in patients with kidney failure who require ongoing hemodialysis.
Clinical Applications
- Providing temporary or long-term central venous access for chronic hemodialysis.
- Connecting a patient to standard hemodialysis equipment for blood removal and return.
- Use in adult patients who require repeated dialysis treatments when a catheter is selected as the dialysis access.
Practical Considerations
- The catheter is a dual-lumen device and must be used with compatible hemodialysis equipment and connectors.
- Available catheter lengths may vary; the appropriate length depends on the patient’s anatomy and the selected venous access route.
- Insertion is generally performed using sterile technique and imaging guidance, commonly through the internal jugular or another central vein.
- MRI safety and conditions should be confirmed in the current manufacturer labeling before an MRI examination; do not assume the device is fully MRI safe.
- Risks include infection, thrombosis, bleeding, vessel injury, malposition, inadequate blood flow and catheter dysfunction. The device should not be used when contraindicated by the labeling or when the catheter is damaged or improperly positioned.
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.