đź“Š Evidence-Based Reference
uldall double lumen hemodialysis catheter set tray
Cook
Summary: The Uldall double lumen hemodialysis catheter set tray by Cook is used for vascular access in hemodialysis patients. Key evidence highlights its technical success and management of complications.
FDA Clearance Information
Pathway 510K
Number K913468 ↗
Decision Date March 24, 1994
Product Code LFJ
Device Class Class 2
Evidence 0 studies
The Uldall double lumen hemodialysis catheter set tray was cleared by the FDA via the 510(k) pathway on March 24, 1994. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Uldall double lumen hemodialysis catheter is designed for providing vascular access in patients undergoing hemodialysis. It facilitates efficient blood flow for dialysis treatment.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease requiring hemodialysis, especially those with refractory vascular access issues. It is inserted percutaneously and can be used for long-term dialysis access.
Evidence Summary
The available literature includes 7 studies ranging from 1991 to 1997, encompassing various study types such as RCTs and case series. These studies evaluate technical success, complication rates, and catheter patency.
Reported Outcomes
Published studies report that the Uldall catheter is effective in maintaining vascular access for hemodialysis, with technical success in placement and management of patency using anticoagulants. Outcomes include successful infection management by catheter exchange over a guidewire.
Safety Profile
Reported complications include septicemia, which can be managed by changing the catheter over a guidewire. Thrombus obstruction is another concern, often addressed with anticoagulants and thrombolytic agents like urokinase.
Evidence Limitations
The evidence is limited by the small number of studies and the retrospective nature of some analyses. Further research is needed to evaluate long-term outcomes and compare efficacy with newer devices.
Frequently Asked Questions
What are the clinical indications for Uldall double lumen hemodialysis catheter?
The catheter is indicated for use in patients requiring vascular access for hemodialysis, particularly those with difficult vascular access.
What outcomes have been reported in clinical studies?
Studies report successful catheter placement, maintenance of patency, and effective management of infections and thrombus obstructions.
What complications have been reported?
Safety data indicate complications such as septicemia and thrombus obstruction, which are managed with catheter exchange and anticoagulants.
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.