Tunneled dialysis catheters
UltraStream Chronic Dialysis Catheter Exchange Kit
by Argon Medical Devices, Inc.
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
UltraStream Chronic Dialysis Catheter Exchange Kit models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 32001524 | — | Not stated | Available |
| 32001528 | — | Not stated | Available |
| 32001532 | — | Not stated | Available |
| 32001536 | — | Not stated | Available |
| 32001540 | — | Not stated | Available |
FDA clearances
- 510(k) K102043 November 2010
Procedures that use tunneled dialysis catheters
Frequently asked questions
What is UltraStream Chronic Dialysis Catheter Exchange Kit used for?
An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.
Who makes UltraStream Chronic Dialysis Catheter Exchange Kit?
UltraStream Chronic Dialysis Catheter Exchange Kit is made by Argon Medical Devices, Inc.. It is listed under tunneled dialysis catheters (permcath) in our device library.
What sizes does UltraStream Chronic Dialysis Catheter Exchange Kit come in?
The FDA device database does not list sizes for UltraStream Chronic Dialysis Catheter Exchange Kit. Check the instructions for use or ask a Argon Medical Devices, Inc. representative.
Is UltraStream Chronic Dialysis Catheter Exchange Kit MRI safe?
The FDA device database entry for UltraStream Chronic Dialysis Catheter Exchange Kit does not state its MRI safety status. Check the labeling before MRI.
Is UltraStream Chronic Dialysis Catheter Exchange Kit FDA cleared?
UltraStream Chronic Dialysis Catheter Exchange Kit is covered by FDA submission K102043.
How do I contact a Argon Medical Devices, Inc. sales representative?
Argon Medical Devices, Inc. has not listed representatives on LA Vascular yet. Visit the Argon Medical Devices, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.