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integral hemodialysis catheter
Arrow Int'L.
Summary: The integral hemodialysis catheter by Arrow Int'L. is used for vascular access in hemodialysis. Key evidence highlights its role in managing dialysis access with noted complications such as central vein stenosis.
FDA Clearance Information
Pathway
510K
Number
K040260 ↗
Decision Date
March 5, 2004
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The integral hemodialysis catheter was cleared via the FDA 510(k) pathway on March 5, 2004. It is manufactured by Arrow Int'L. and classified as a Class 2 device.
What It Is
The integral hemodialysis catheter is a medical device designed to provide vascular access for hemodialysis. It is intended for patients requiring dialysis when other forms of vascular access are not feasible.
Clinical Applications
This catheter is commonly used in patients with chronic kidney disease who require long-term hemodialysis. It is particularly useful when arteriovenous fistulas or grafts are not viable options.
Evidence Summary
The literature includes 9 studies, comprising retrospective analyses and case reports, published between 2018 and 2025. These studies explore various aspects of catheter use, including positioning and complications.
Reported Outcomes
Published studies report that the integral hemodialysis catheter effectively provides vascular access for dialysis. However, complications such as catheter-related bloodstream infections and mechanical issues like vein obstruction have been noted.
Safety Profile
Reported complications include central vein stenosis, thrombosis, and catheter-related bloodstream infections. Proper insertion techniques and imaging guidance are recommended to mitigate these risks.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the lack of large-scale randomized controlled trials. Further research is needed to optimize insertion techniques and reduce complication rates.
Frequently Asked Questions
What are the clinical indications for integral hemodialysis catheter?
The catheter is indicated for patients requiring vascular access for hemodialysis, particularly when other access methods are not feasible.
What outcomes have been reported in clinical studies?
Studies report effective dialysis access but highlight risks of infections and mechanical complications.
What complications have been reported?
Safety data indicate risks of central vein stenosis, thrombosis, and catheter-related bloodstream infections.
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.