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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 ?
510(k)
Number ?
K203767 ↗
Decision Date ?
April 2, 2021
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
Clinical Applications
- Providing access for repeated hemodialysis treatments.
- Use when an arteriovenous fistula or graft is not available, cannot be used, or is not yet ready.
- Placement through a large central vein for connection to standard hemodialysis equipment.
Practical Considerations
- The catheter is available in different configurations and sizes; selection depends on the patient's anatomy, blood-flow requirements, and dialysis prescription.
- It is generally placed using ultrasound and fluoroscopic guidance, commonly through the internal jugular vein, with the catheter tunneled under the skin to a chest exit site.
- The catheter must be handled and maintained using sterile technique to reduce bloodstream infection, catheter dysfunction, and thrombosis.
- Compatibility with dialysis equipment, locking solutions, and any special imaging conditions should be confirmed in the manufacturer's instructions for use.
- Contraindications, access-site limitations, and MRI conditions should be checked in the current device labeling; the FDA clearance alone does not establish that every configuration is MRI safe.
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.