đź“Š Evidence-Based Reference
duraspan hemodialysis long-term catheter models 62152420 621512820 62153220 62153620 62154020 62155520
R4 Vascular
Summary: The Duraspan Hemodialysis Catheter is a long-term dialysis access device. It is primarily used for patients requiring hemodialysis. Key evidence highlights its effectiveness and safety across various studies.
FDA Clearance Information
Pathway 510K
Number K091506 ↗
Decision Date January 8, 2010
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Duraspan Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on January 8, 2010. It is manufactured by R4 Vascular and classified as a Class 2 device under product code MSD.
What It Is
The Duraspan Hemodialysis Catheter is a tunneled catheter designed for long-term vascular access in patients undergoing hemodialysis. It facilitates efficient blood flow and is intended for use in patients with end-stage renal disease.
Clinical Applications
Commonly used in clinical settings for patients requiring long-term hemodialysis, the Duraspan Catheter is often employed when other forms of vascular access are not viable. It is inserted into a central vein to provide reliable access for dialysis sessions.
Evidence Summary
The available literature includes a variety of study types such as RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Duraspan Hemodialysis Catheter is effective in providing long-term vascular access for hemodialysis. Comparative studies indicate favorable outcomes in terms of catheter longevity and functionality. Meta-analyses suggest that different tip designs may influence effectiveness and safety.
Safety Profile
Reported complications include catheter-associated bloodstream infections and other catheter-related complications that may interrupt treatment. Studies highlight the importance of monitoring for these adverse events to ensure patient safety.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and to compare the Duraspan Catheter with other hemodialysis access devices in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Duraspan Hemodialysis Catheter?
The Duraspan Hemodialysis Catheter is indicated for long-term vascular access in patients requiring hemodialysis, particularly when other access methods are not suitable.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective long-term vascular access with the Duraspan Catheter, with favorable outcomes in terms of catheter longevity and functionality.
What complications have been reported?
Reported complications include catheter-associated bloodstream infections and other catheter-related issues that may lead to treatment interruptions.
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.