đź“‹ FDA Reference
modification to uldall double lumen hemodialysis catheter set and tray
Cook
Summary: The Uldall Double Lumen Hemodialysis Catheter Set is a medical device used for hemodialysis access. It is primarily used by nephrologists and dialysis nurses for patients requiring renal replacement therapy.
FDA Clearance Information
Pathway
510K
Number
K982333 ↗
Decision Date
February 12, 1999
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Uldall Double Lumen Hemodialysis Catheter Set by Cook was cleared via the FDA 510k pathway on February 12, 1999. It is classified as a Class 2 medical device.
What It Is
The Uldall Double Lumen Hemodialysis Catheter Set is a specialized catheter designed for temporary vascular access in patients undergoing hemodialysis. It consists of two lumens, allowing simultaneous arterial and venous blood flow. This facilitates efficient blood filtration and is crucial for patients with acute or chronic renal failure who require dialysis.
Clinical Applications
This device is commonly used in hospital settings, dialysis centers, and sometimes in outpatient clinics. It is primarily utilized by nephrologists and dialysis nurses for patients with end-stage renal disease or acute kidney injury who need immediate dialysis. The catheter is typically inserted into a large central vein, such as the internal jugular or subclavian vein.
Indications for Use
The Uldall Double Lumen Hemodialysis Catheter Set is indicated for patients who need temporary vascular access for hemodialysis. It is suitable for those with renal failure requiring immediate dialysis access, often while awaiting more permanent solutions like an arteriovenous fistula.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard dialysis machines. Proper insertion technique is crucial to minimize complications such as infection or thrombosis. Clinicians should be trained in central venous catheter placement.
Frequently Asked Questions
What is the Uldall Double Lumen Hemodialysis Catheter Set used for?
It is used for providing temporary vascular access for hemodialysis in patients with renal failure.
What specialties typically use this device?
Nephrologists and dialysis nurses in hospital and dialysis center settings typically use this device.
What are the FDA-cleared indications?
It is indicated for temporary vascular access in patients needing hemodialysis due to 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.