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duet long-term hemodialysis catheter system duet long-term hemodialysis catheter system catheter repair kit
C.R. Bard
Summary: The Duet Long-Term Hemodialysis Catheter System is a medical device used for hemodialysis in patients requiring long-term vascular access. It is primarily used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K090528 ↗
Decision Date May 28, 2009
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Duet Long-Term Hemodialysis Catheter System was cleared via the FDA 510(k) pathway on May 28, 2009. Manufactured by C.R. Bard, it is a Class 2 device under product code MSD.
What It Is
The Duet Long-Term Hemodialysis Catheter System is designed to provide long-term vascular access for patients undergoing hemodialysis. It consists of a catheter that is inserted into a large vein, typically in the chest, to facilitate the removal and return of blood during dialysis sessions. The system includes a catheter repair kit to address potential issues without the need for complete device replacement.
Clinical Applications
This device is commonly used in patients with chronic kidney disease who require regular hemodialysis. It is typically utilized in hospital settings, dialysis centers, and sometimes in outpatient clinics. Nephrologists and vascular surgeons are the primary specialists involved in the placement and management of these catheters, especially in patients who are not candidates for arteriovenous fistulas or grafts.
Indications for Use
The Duet Long-Term Hemodialysis Catheter System is indicated for patients who need long-term vascular access for hemodialysis. It is suitable for individuals with chronic kidney failure who require regular dialysis treatments.
Practical Considerations
The catheter system comes in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper insertion technique and maintenance are crucial to minimize infection risk and ensure device longevity.
Frequently Asked Questions
What is the Duet Long-Term Hemodialysis Catheter System used for?
It is used to provide long-term vascular access for patients undergoing regular hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device for patients requiring long-term hemodialysis.
What are the FDA-cleared indications?
The device is indicated for long-term vascular access in patients needing hemodialysis due to chronic 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.