đź“‹ FDA Reference
Centros Long-Term Hemodialysis Catheter Centrosflo Long-Term Hemodialysis Catheter
Summary: The Centros Long-Term Hemodialysis Catheter is a medical device used for providing vascular access for hemodialysis in patients with kidney failure. It is typically used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151967 ↗
Decision Date ?
April 4, 2016
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Centros Long-Term Hemodialysis Catheter, manufactured by Merit Medical Systems, was cleared through the FDA 510(k) pathway on April 4, 2016. It is classified as a Class 2 device under product code MSD.
What It Is
The Centros Long-Term Hemodialysis Catheter is a specialized catheter designed for long-term vascular access in patients requiring hemodialysis. It is inserted into a large central vein, typically the internal jugular or subclavian vein, to facilitate efficient blood flow during dialysis sessions. The catheter's design helps minimize complications such as thrombosis and infection, which are common in long-term vascular access devices.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients with end-stage renal disease.
- Use in patients who require ongoing hemodialysis and do not have suitable vascular access through an arteriovenous fistula or graft.
Clinical Applications
- Providing central venous access for repeated hemodialysis treatments.
- Hemodialysis access when an arteriovenous fistula or graft is not suitable, not available, or cannot be used.
- Use in dialysis centers, hospitals, and other clinical settings where maintenance hemodialysis is performed.
Practical Considerations
- The catheter is placed in a large central vein, commonly the internal jugular vein; the exact access site depends on the patient's anatomy, prior access history, and clinical needs.
- Placement is generally performed with ultrasound and fluoroscopic imaging, using local anesthesia with or without moderate sedation.
- The catheter must be handled using strict aseptic technique and requires regular dressing changes, flushing, and monitoring for infection, thrombosis, poor blood flow, or dislodgement.
- The catheter is intended for connection to standard hemodialysis equipment; dialysis staff should follow the device instructions for use and locking solution.
- MRI safety depends on the specific catheter model and labeling. The exact product documentation should be checked before MRI, and the catheter should not be assumed to be MRI safe without verification.
Frequently Asked Questions
What is the Centros Long-Term Hemodialysis Catheter used for?
It is used to provide long-term vascular access for hemodialysis in patients with kidney failure.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for providing long-term vascular access for 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.