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glidepath long-term hemodialysis catheters hemostar long-term hemodialysis catheters hemostar xk long-term hemodialysis catheters
C. R. Bard
Summary: The Glidepath and Hemostar long-term hemodialysis catheters are used for vascular access in patients requiring long-term hemodialysis. They are typically utilized by nephrologists and vascular surgeons in hospital or dialysis center settings.
FDA Clearance Information
Pathway 510K
Number K190527 ↗
Decision Date March 5, 2020
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Glidepath and Hemostar catheters were cleared through the FDA 510(k) pathway on March 5, 2020, by C. R. Bard. They are classified as Class II medical devices under product code MSD.
What It Is
These catheters are specialized medical devices designed for long-term vascular access in patients undergoing hemodialysis. They are inserted into large veins, typically in the neck or chest, to facilitate efficient blood flow during dialysis sessions. The catheters are constructed to minimize infection risk and ensure durability over extended periods.
Clinical Applications
These catheters are commonly used in patients with chronic kidney disease who require regular hemodialysis. They are typically placed by nephrologists or interventional radiologists in hospital settings or specialized dialysis centers. The devices are crucial for patients who do not have a functioning arteriovenous fistula or graft.
Indications for Use
These catheters are indicated for patients needing long-term hemodialysis access. They are suitable for individuals with chronic kidney failure who require regular dialysis but lack other forms of vascular access.
Practical Considerations
The catheters come in various sizes to accommodate different patient anatomies and are compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is Glidepath & Hemostar used for?
These catheters are used for providing long-term vascular access for patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists, vascular surgeons, and interventional radiologists typically use these devices.
What are the FDA-cleared indications?
The catheters are indicated for long-term vascular access in patients requiring hemodialysis.
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.