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glidepath 13f long-term hemodialysis catheter
Bard Peripheral Vascular
Summary: The Glidepath 13F Long-Term Hemodialysis Catheter is a medical device used for facilitating hemodialysis in patients with renal failure. It is typically used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K211410 ↗
Decision Date
June 4, 2021
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Glidepath 13F Long-Term Hemodialysis Catheter was cleared through the FDA 510(k) pathway on June 4, 2021, by Bard Peripheral Vascular. It is classified as a Class 2 device under product code MSD.
What It Is
The Glidepath 13F Long-Term Hemodialysis Catheter is designed to provide reliable vascular access for hemodialysis treatments. It is a flexible tube inserted into a large vein, typically in the neck or chest, allowing for efficient blood flow during dialysis sessions. The catheter's design aims to minimize complications such as clotting or infection, which are common concerns in long-term dialysis access.
Clinical Applications
This catheter is primarily used in patients with chronic kidney disease requiring long-term hemodialysis. It is commonly placed in hospital settings or outpatient dialysis centers by nephrologists or interventional radiologists. The device is suitable for adult patients who need consistent and reliable access to their bloodstream for dialysis treatments.
Indications for Use
The FDA-cleared indications for this catheter are for patients who require long-term vascular access for hemodialysis. It is intended for those with end-stage renal disease or chronic kidney failure who need regular dialysis sessions.
Practical Considerations
The Glidepath 13F catheter is typically available in various lengths to accommodate different patient anatomies and insertion sites. It is important to ensure compatibility with the dialysis machine and to follow aseptic techniques during insertion to reduce infection risk.
Frequently Asked Questions
What is the Glidepath 13F Hemodialysis Catheter used for?
It is used to provide long-term vascular access for patients undergoing hemodialysis due to renal failure.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device in hospital or dialysis center settings.
What are the FDA-cleared indications?
The catheter is indicated for patients needing long-term vascular access for hemodialysis, such as those with 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.