📋 FDA Reference
Modification to Uldall Double Lumen Hemodialysis Catheter Set and Tray
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 ?
510(k)
Number ?
K982333 ↗
Decision Date ?
February 12, 1999
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Temporary vascular access for hemodialysis in patients who require renal replacement therapy.
- Use when immediate dialysis access is needed, including while a more permanent access is established.
Clinical Applications
- Temporary central venous access for hemodialysis.
- Hemodialysis access for patients with acute kidney injury or renal failure when immediate treatment is required.
- Bridge access while an arteriovenous fistula or graft is created and matures.
Practical Considerations
- The catheter is intended for trained clinicians experienced in central venous catheter placement and dialysis access management.
- Placement commonly uses ultrasound and fluoroscopic or other imaging guidance, depending on the access site and clinical setting.
- Available catheter sizes and lengths should be selected according to the patient's anatomy, access vessel, and dialysis requirements.
- The catheter must be connected to compatible hemodialysis equipment and handled using strict sterile technique.
- MRI safety should be confirmed in the current product labeling before scanning; the FDA record alone does not establish that the device is MR safe or MR conditional.
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.