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glidepath retro long-term hemodialysis catheter
C.R. Bard
Summary: The Glidepath Retro Long-Term Hemodialysis Catheter by C.R. Bard is a medical device used for long-term hemodialysis. It is primarily utilized by nephrologists and vascular surgeons for patients requiring dialysis access.
FDA Clearance Information
Pathway
510K
Number
K203575 ↗
Decision Date
July 1, 2021
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Glidepath Retro Long-Term Hemodialysis Catheter was cleared through the FDA 510k pathway on July 1, 2021. Manufactured by C.R. Bard, it is classified as a Class 2 medical device under product code MSD.
What It Is
The Glidepath Retro Long-Term Hemodialysis Catheter is a specialized catheter designed for long-term vascular access in patients undergoing hemodialysis. It is typically inserted into a central vein, such as the internal jugular or subclavian vein, to facilitate efficient blood flow during dialysis sessions. The catheter's design ensures durability and minimizes complications such as infection or thrombosis, making it suitable for long-term use.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically placed by nephrologists or vascular surgeons in hospital settings or outpatient dialysis centers. The device is particularly beneficial for patients who do not have suitable arteriovenous fistulas or grafts, providing an alternative means of vascular access.
Indications for Use
The FDA-cleared indications for this catheter include providing long-term vascular access for patients undergoing hemodialysis. It is intended for use in patients who need reliable and durable access to the bloodstream for dialysis treatments.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper insertion technique and maintenance are crucial to prevent complications such as infection or catheter malfunction.
Frequently Asked Questions
What is the Glidepath Retro 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 vascular surgeons typically use this device in clinical settings.
What are the FDA-cleared indications?
The catheter is 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.