đź“‹ FDA Reference
pristine long-term hemodialysis catheter
C B Bard
Summary: The Pristine Long-Term Hemodialysis Catheter by C B Bard is used for long-term vascular access in patients requiring hemodialysis. It is primarily used by nephrologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K203767 ↗
Decision Date April 2, 2021
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Pristine Long-Term Hemodialysis Catheter was cleared through the FDA 510(k) pathway on April 2, 2021. It is manufactured by C B Bard and classified as a Class 2 device under product code MSD.
What It Is
The Pristine Long-Term Hemodialysis Catheter is a medical device designed to provide reliable vascular access for patients undergoing hemodialysis. It is typically inserted into a large central vein, such as the internal jugular or subclavian vein, allowing for efficient blood flow during dialysis sessions. The catheter is made of biocompatible materials to minimize the risk of infection and thrombosis, and it is designed for long-term use, reducing the need for frequent replacements.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require regular hemodialysis. It is typically placed in hospital settings by nephrologists or vascular surgeons. The device is suitable for adult and pediatric patients who need long-term dialysis access, especially when other forms of access, like arteriovenous fistulas, are not viable. It is also used in patients awaiting kidney transplantation.
Indications for Use
The Pristine Long-Term Hemodialysis Catheter is indicated for use in patients who require long-term vascular access for hemodialysis. This includes individuals with chronic kidney disease who need regular dialysis treatments to manage their condition.
Practical Considerations
The catheter comes in various sizes to accommodate different patient anatomies and is compatible with standard dialysis equipment. Proper insertion technique is crucial to minimize complications such as infection or thrombosis. Clinicians should be trained in catheter placement and maintenance protocols.
Related Literature
The Pristine Post-Market Study aimed to evaluate the safety and efficacy of the Pristine Long-Term Hemodialysis Catheter in real-world settings. Although specific details and findings are not available, such studies typically assess device performance, complication rates, and patient outcomes. Limitations may include a lack of detailed data or a small sample size.
Frequently Asked Questions
What is the Pristine Long-Term Hemodialysis Catheter used for?
It is used for providing long-term vascular access in patients requiring hemodialysis.
What specialties typically use this device?
Nephrologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring long-term vascular access for hemodialysis, such as those with chronic kidney disease.
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.