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lifejet f16 hemodialysis apheresis chronic catheter
Horizon Medical Products
Summary: The lifejet f16 is a hemodialysis apheresis catheter used for chronic dialysis access. It is primarily used by nephrologists in patients requiring long-term dialysis.
FDA Clearance Information
Pathway
510K
Number
K022905 ↗
Decision Date
December 13, 2002
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The lifejet f16 hemodialysis catheter was cleared via the FDA 510(k) pathway on December 13, 2002. Manufactured by Horizon Medical Products, it is classified as a Class 2 device.
What It Is
The lifejet f16 is a chronic hemodialysis apheresis catheter designed to provide reliable vascular access for patients undergoing long-term dialysis. It is typically inserted into a central vein, such as the internal jugular or subclavian vein, and facilitates the removal and return of blood during dialysis sessions. The catheter is designed to minimize complications such as thrombosis and infection, which are common concerns in dialysis patients.
Clinical Applications
This catheter is commonly used in nephrology for patients with end-stage renal disease (ESRD) who require regular hemodialysis. It is often employed in hospital settings, dialysis centers, and sometimes in outpatient clinics. The device is suitable for patients who have exhausted other forms of vascular access or those who need immediate dialysis access while awaiting a more permanent solution like an arteriovenous fistula.
Indications for Use
The lifejet f16 is indicated for patients needing chronic hemodialysis access. It is suitable for individuals with ESRD who require long-term dialysis treatment and have limited vascular access options.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications, and clinicians should be trained in central venous catheter placement.
Frequently Asked Questions
What is lifejet f16 used for?
The lifejet f16 is used for providing chronic vascular access for hemodialysis in patients with end-stage renal disease.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device, especially in dialysis centers and hospitals.
What are the FDA-cleared indications?
The device is indicated for chronic hemodialysis access in patients requiring long-term dialysis treatment.
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.