đź“‹ FDA Reference
24cm Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated TIPS
Spire Biomedical
Summary: The 24cm Pourchez Xpresso Twin Lumen Catheter is a chronic hemodialysis catheter used for vascular access in patients requiring dialysis. It is primarily used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K021212 ↗
Decision Date ?
May 17, 2002
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The 24cm Pourchez Xpresso Twin Lumen Catheter was cleared via the FDA 510k pathway on May 17, 2002. Manufactured by Spire Biomedical, it is classified as a Class 2 device.
What It Is
The 24cm Pourchez Xpresso Twin Lumen Catheter is a specialized vascular access device designed for chronic hemodialysis. It features twin lumens with separated tips to facilitate efficient blood flow during dialysis sessions. The catheter is inserted into a large central vein, typically the internal jugular, to provide reliable access for repeated dialysis treatments.
FDA-Cleared Indications
- Vascular access for chronic hemodialysis.
- Use in patients who require repeated hemodialysis treatments.
Clinical Applications
- Providing temporary or longer-term central venous access for chronic hemodialysis.
- Connecting a patient to a hemodialysis machine through separate blood-withdrawal and blood-return lumens.
- Use when a patient needs catheter-based dialysis access rather than an arteriovenous fistula or graft.
Practical Considerations
- The 24 cm length is one catheter size; the appropriate length and insertion site depend on the patient’s anatomy and the selected central vein.
- Placement is commonly performed through the internal jugular vein, with imaging guidance used to confirm venous access and catheter position.
- The catheter must be compatible with the dialysis equipment and handled using strict aseptic technique to reduce infection risk.
- Potential complications include infection, thrombosis, bleeding, vessel injury, catheter malfunction, air embolism and malposition.
- MRI safety and conditions should be confirmed in the current manufacturer labeling; do not assume the catheter is MRI safe or MRI conditional without that information.
Frequently Asked Questions
What is the 24cm Pourchez Xpresso Twin Lumen Catheter used for?
It is used for providing vascular access in patients requiring chronic hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for patients requiring chronic hemodialysis, providing reliable vascular access.
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.