đź“‹ FDA Reference
55cm pourchez retro safe trac twin lumen hemodialysis catheter model rs50sh55 rs50nh55 re50sh55 re50nh55
Spire Biomedical
Summary: The Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter is a medical device used for hemodialysis in patients requiring renal replacement therapy. It is typically used by nephrologists and dialysis nurses.
FDA Clearance Information
Pathway
510K
Number
K041559 ↗
Decision Date
July 30, 2004
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Pourchez Retro Safe Trac Catheter was cleared through the FDA 510(k) pathway on July 30, 2004. It is manufactured by Spire Biomedical and classified as a Class 2 device under product code MSD.
What It Is
The Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter is designed for temporary vascular access in patients undergoing hemodialysis. It features a twin lumen design, allowing for simultaneous blood withdrawal and return, which is critical for efficient dialysis treatment. The catheter is inserted into a large central vein, typically the internal jugular or subclavian vein, and is intended for short-term use.
Clinical Applications
This catheter is commonly used in hospital settings, dialysis centers, and sometimes in outpatient clinics for patients with acute or chronic kidney failure who require hemodialysis. It is particularly useful in emergency situations where immediate dialysis access is needed. Nephrologists and dialysis nurses are the primary users of this device, and it is suitable for adult patients requiring temporary dialysis access.
Indications for Use
The FDA indications for this catheter include providing temporary vascular access for hemodialysis in patients with renal failure. It is intended for use in patients who need short-term dialysis access, such as those awaiting permanent access placement or those with acute kidney injury.
Practical Considerations
The catheter is typically available in a 55cm length, which is suitable for most adult patients. It is important to ensure compatibility with the dialysis machine and to follow proper insertion techniques to minimize complications such as infection or thrombosis.
Frequently Asked Questions
What is the Pourchez Retro Safe Trac Catheter used for?
It is used for temporary vascular access in patients undergoing hemodialysis.
What specialties typically use this device?
Nephrologists and dialysis nurses typically use this device.
What are the FDA-cleared indications?
The catheter is indicated for temporary vascular access for hemodialysis in patients with renal failure.
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.