đź“‹ FDA Reference
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
510K
Number
K022000 ↗
Decision Date
July 19, 2002
Product Code
MSD
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.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require long-term hemodialysis. It is typically placed by nephrologists or interventional radiologists in hospital or outpatient settings. The device is suitable for patients who do not have a functioning arteriovenous fistula or graft and require a more permanent vascular access solution.
Indications for Use
The FDA indications suggest that this catheter is intended for patients needing chronic hemodialysis. It is particularly useful for those who require a durable and reliable access point for repeated dialysis sessions.
Practical Considerations
The catheter is available in various lengths to accommodate different patient anatomies and insertion sites. Compatibility with dialysis machines and anticoagulation protocols should be considered. Proper insertion technique is crucial to minimize infection risk and ensure optimal function.
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.