📋 FDA Reference
Equistream Long-Term Hemodialysis Catheters
Summary: The Equistream long-term hemodialysis catheter is a medical device used for vascular access in patients requiring hemodialysis. It is primarily used by nephrologists and dialysis specialists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090101 ↗
Decision Date ?
February 10, 2009
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Equistream long-term hemodialysis catheter, manufactured by C.R. Bard, was cleared via the FDA 510(k) pathway on February 10, 2009. It is classified as a Class 2 device under product code MSD.
What It Is
The Equistream long-term hemodialysis catheter is a specialized vascular access device designed for patients undergoing hemodialysis. It is typically inserted into a large central vein, such as the internal jugular or subclavian vein, to facilitate the efficient removal and return of blood during dialysis sessions. The catheter is designed for long-term use, providing a reliable and stable access point for patients who require ongoing dialysis treatment.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients requiring chronic or repeated hemodialysis treatment.
- Use when a suitable arteriovenous fistula or graft is unavailable, unusable, or not yet ready for dialysis.
Clinical Applications
- Providing access for repeated hemodialysis sessions in patients with chronic kidney disease or end-stage kidney disease.
- Connecting a patient to standard hemodialysis equipment for blood withdrawal and return.
- Providing dialysis access while an arteriovenous fistula or graft is being created or matures, when consistent with the product labeling and clinical plan.
- Providing long-term dialysis access when permanent arteriovenous access is not possible or is unsuitable.
Practical Considerations
- The catheter is generally placed in a large central vein, most commonly the internal jugular vein, with the catheter tunneled under the skin to a separate exit site.
- Placement is typically performed with ultrasound and fluoroscopic or other imaging guidance, using local anesthesia with or without moderate sedation.
- Available catheter lengths and configurations should be selected according to patient anatomy, intended tip position, blood-flow requirements, and the dialysis system.
- Strict sterile insertion and exit-site care are essential because tunneled dialysis catheters can cause bloodstream infection, thrombosis, malfunction, bleeding, or central venous stenosis.
- MRI safety depends on the exact catheter model and any associated components; the device-specific labeling should be checked before MRI. A catheter should not be assumed to be MRI safe based only on its product name.
Frequently Asked Questions
What is Equistream 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 dialysis specialists typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for long-term vascular access in patients requiring hemodialysis, particularly those without suitable arteriovenous fistulas or grafts.
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.