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Glidepath Long-Term Hemodialysis Catheters Hemostar Long-Term Hemodialysis Catheters Hemostar Xk Long-Term Hemodialysis Catheters
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 ?
510(k)
Number ?
K190527 ↗
Decision Date ?
March 5, 2020
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients requiring repeated hemodialysis treatments.
- Access through a large central vein for withdrawal and return of blood during dialysis.
Clinical Applications
- Providing tunneled central venous access for chronic hemodialysis.
- Connecting a patient to standard hemodialysis equipment for recurring treatments.
- Providing dialysis access when a functioning arteriovenous fistula or graft is unavailable or unsuitable.
- Placement in a hospital, interventional radiology suite, or dialysis-access setting by qualified clinicians.
Practical Considerations
- Available catheter configurations and sizes should be selected for the patient's anatomy, dialysis prescription, and access site.
- The catheter is placed into a large central vein, commonly through the internal jugular vein, with the catheter tunneled under the skin before it exits the chest.
- Strict sterile technique and catheter-care protocols are important because infection, bloodstream infection, thrombosis, and catheter malfunction are possible.
- The catheter should be used only with compatible dialysis equipment and according to the manufacturer's instructions for use.
- MRI safety depends on the exact catheter model and labeling; confirm the specific model's MR status before an MRI examination.
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.