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Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated TIPS with and Without Side Holes
Spire Biomedical
Summary: The Pourchez Retro Twin Lumen Catheter is a chronic hemodialysis catheter used for vascular access in patients requiring long-term dialysis. It is typically used by nephrologists and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K022000 ↗
Decision Date ?
July 19, 2002
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Pourchez Retro Twin Lumen Catheter was cleared via the FDA 510(k) pathway on July 19, 2002. It is manufactured by Spire Biomedical and is classified as a Class 2 device under product code MSD.
What It Is
The Pourchez Retro Twin Lumen Catheter is a specialized vascular access device designed for chronic hemodialysis. It features twin lumens with separated tips, which facilitate efficient blood flow during dialysis sessions. The catheter may come with or without side holes, which can influence flow dynamics and clotting risk. This device is inserted into a central vein, typically the internal jugular, to provide reliable and repeated access to the bloodstream.
FDA-Cleared Indications
- Vascular access for patients requiring chronic hemodialysis.
- Repeated withdrawal and return of blood during hemodialysis.
- Use as an implanted hemodialysis catheter when durable central venous access is needed.
Clinical Applications
- Providing repeated vascular access for chronic hemodialysis.
- Withdrawing blood from the bloodstream for passage through a dialysis machine.
- Returning dialyzed blood to the patient through a separate catheter lumen.
- Placement in a central vein, commonly the internal jugular vein, when long-term dialysis access is required.
Practical Considerations
- The catheter is available in different lengths to match the selected venous access site and patient anatomy.
- It is designed for connection to compatible hemodialysis equipment; dialysis staff should follow the catheter and machine instructions for use.
- The device may have side holes or separated tips without side holes, and the configuration can affect blood-flow behavior and catheter management.
- Placement requires sterile technique and imaging guidance as appropriate to reduce malposition, bleeding, thrombosis and infection risks.
- MRI conditions should be confirmed in the current device labeling before scanning; do not assume MRI safety from the device name alone.
Frequently Asked Questions
What is the Pourchez Retro 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 use in patients needing chronic hemodialysis 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.