đź“‹ FDA Reference
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 510K
Number K013160 ↗
Decision Date April 11, 2002
Product Code MSD
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.
Clinical Applications
This catheter is primarily used in nephrology and dialysis settings, where patients require ongoing hemodialysis due to chronic kidney disease. It is often employed in hospital dialysis units, outpatient dialysis centers, and sometimes in home dialysis setups. The device is suitable for adult patients who need consistent and reliable vascular access over extended periods.
Indications for Use
The FDA indications for this catheter include providing vascular access for patients undergoing chronic hemodialysis. It is specifically designed for individuals with end-stage renal disease who require regular dialysis treatment.
Practical Considerations
The Pourchez Xpresso Twin Lumen Catheter is available in various sizes to accommodate different patient anatomies. It is compatible with standard dialysis equipment and requires careful insertion and maintenance to prevent complications such as infection or thrombosis.
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.