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Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter
Spire Biomedical
Summary: The Pourchez Xpresso Twin Lumen Catheter is a medical device used for chronic hemodialysis. It is utilized by nephrologists and dialysis centers for patients requiring long-term vascular access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K013160 ↗
Decision Date ?
April 11, 2002
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Pourchez Xpresso Twin Lumen Catheter was cleared via the FDA 510k pathway on April 11, 2002. Manufactured by Spire Biomedical, it is classified as a Class 2 medical device under product code MSD.
What It Is
The Pourchez Xpresso Twin Lumen Catheter is a specialized catheter designed for chronic hemodialysis. It features two lumens, allowing for simultaneous blood withdrawal and return, which is essential for efficient dialysis treatment. The catheter is typically inserted into a large central vein, providing reliable vascular access for patients undergoing long-term dialysis.
FDA-Cleared Indications
- Vascular access for patients undergoing chronic hemodialysis.
- Use in patients who require long-term implanted venous access for hemodialysis.
Clinical Applications
- Long-term central venous access for chronic hemodialysis.
- Blood withdrawal and return during hemodialysis through separate catheter lumens.
- Use in dialysis units or hospital-based dialysis settings when durable vascular access is needed.
Practical Considerations
- The catheter is implanted in a large central vein, with the tip positioned in a central thoracic vein or the right atrium according to the treating clinician's technique and product instructions.
- Available catheter sizes and lengths may vary; selection depends on the patient's anatomy, access route and dialysis requirements.
- It connects to standard hemodialysis tubing and equipment through its two separate lumens.
- Insertion and maintenance require sterile technique because infection, thrombosis, bleeding, catheter malfunction and central venous injury are possible complications.
- MRI safety should be confirmed in the current manufacturer labeling for the specific catheter configuration; do not assume that an implanted catheter is MRI safe or MRI conditional.
Frequently Asked Questions
What is the Pourchez Xpresso Twin Lumen Catheter used for?
It is used for providing vascular access in patients undergoing chronic hemodialysis.
What specialties typically use this device?
Nephrologists and healthcare professionals in dialysis centers commonly use this device.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for chronic hemodialysis in patients with end-stage renal 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.