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equistream long-term hemodialysis catheters
C.R. Bard
Summary: The Equistream long-term hemodialysis catheter is a medical device used for vascular access in patients requiring hemodialysis. It is primarily used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway
510K
Number
K090101 ↗
Decision Date
February 10, 2009
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Equistream long-term hemodialysis catheter, manufactured by C.R. Bard, was cleared via the FDA 510(k) pathway on February 10, 2009. It is classified as a Class 2 device under product code MSD.
What It Is
The Equistream long-term hemodialysis catheter is a specialized vascular access device designed for patients undergoing hemodialysis. It is typically inserted into a large central vein, such as the internal jugular or subclavian vein, to facilitate the efficient removal and return of blood during dialysis sessions. The catheter is designed for long-term use, providing a reliable and stable access point for patients who require ongoing dialysis treatment.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease (ESRD) who require long-term hemodialysis. It is typically utilized in hospital settings, dialysis centers, and sometimes in home-care settings. Nephrologists and dialysis nurses are the primary users, and the device is particularly valuable for patients who do not have suitable arteriovenous fistulas or grafts.
Indications for Use
The FDA indications for the Equistream catheter include providing long-term vascular access for hemodialysis in patients with chronic kidney disease. It is intended for use in patients who require regular dialysis sessions and do not have other viable access options.
Practical Considerations
The Equistream catheter is available in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dialysis equipment and requires careful insertion and maintenance to minimize infection risk and ensure proper function. Clinicians should be trained in catheter insertion techniques and follow strict aseptic protocols.
Frequently Asked Questions
What is Equistream long-term hemodialysis catheter used for?
It is used for providing long-term vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis specialists typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for long-term vascular access in patients requiring hemodialysis, particularly those without suitable arteriovenous fistulas or grafts.
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.