Tunneled dialysis catheters
DuraMax
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.
DuraMax 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 |
|---|---|---|---|
| 10302801 | Needle Gauge 18 G; Catheter Gauge 15.5 Fr; Length 20 cm | Not stated | Available |
| 10302802 | Needle Gauge 18 G; Catheter Gauge 15.5 Fr; Length 22 cm | Not stated | Available |
| 10302803 | Length 24 cm; Needle Gauge 18 G; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302804 | Catheter Gauge 15.5 Fr; Length 28 cm; Needle Gauge 18 G | Not stated | Available |
| 10302805 | Catheter Gauge 15.5 Fr; Needle Gauge 18 G; Length 32 cm | Not stated | Available |
| 10302806 | Catheter Gauge 15.5 Fr; Needle Gauge 18 G; Length 36 cm | Not stated | Available |
| 10302807 | Catheter Gauge 15.5 Fr; Needle Gauge 18 G; Length 40 cm | Not stated | Available |
| 10302808 | Needle Gauge 18 G; Catheter Gauge 15.5 Fr; Length 48 cm | Not stated | Available |
| 10302809 | Catheter Gauge 15.5 Fr; Length 55 cm; Needle Gauge 18 G | Not stated | Available |
| 10302816 | Length 20 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302817 | Length 22 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302818 | Catheter Gauge 15.5 Fr; Length 24 cm | Not stated | Available |
| 10302819 | Length 28 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302820 | Catheter Gauge 15.5 Fr; Length 32 cm | Not stated | Available |
| 10302821 | Length 36 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302822 | Catheter Gauge 15.5 Fr; Length 40 cm | Not stated | Available |
| 10302823 | Length 48 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302824 | Catheter Gauge 15.5 Fr; Length 55 cm | Not stated | Available |
| 10302901 | Length 20 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302902 | Length 22 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302903 | Catheter Gauge 15.5 Fr; Length 24 cm | Not stated | Available |
| 10302904 | Length 28 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302905 | Catheter Gauge 15.5 Fr; Length 32 cm | Not stated | Available |
| 10302906 | Catheter Gauge 15.5 Fr; Length 36 cm | Not stated | Available |
| 10302907 | Length 40 cm; Catheter Gauge 15.5 Fr | Not stated | Available |
| 10302908 | Catheter Gauge 15.5 Fr; Length 48 cm | Not stated | Available |
| 10302909 | Catheter Gauge 15.5 Fr; Length 55 cm | Not stated | Available |
FDA clearances
- 510(k) K101843 October 2010
Procedures that use tunneled dialysis catheters
Frequently asked questions
What is DuraMax 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 DuraMax?
DuraMax is made by AngioDynamics, Inc.. It is listed under tunneled dialysis catheters (permcath) in our device library.
What sizes does DuraMax come in?
Sizes listed for DuraMax: Catheter Gauge: 15.5 Fr; Length: 20–55 cm; Needle Gauge: 18 G. Confirm availability with the manufacturer's instructions for use.
Is DuraMax MRI safe?
The FDA device database entry for DuraMax does not state its MRI safety status. Check the labeling before MRI.
Is DuraMax FDA cleared?
DuraMax is covered by FDA submission K101843.
How do I contact a AngioDynamics, Inc. sales representative?
AngioDynamics, Inc. has not listed representatives on LA Vascular yet. Visit the AngioDynamics, 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.