Tunneled dialysis catheters
Tandem-Cath
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.
Tandem-Cath 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 |
|---|---|---|---|
| 8888200006 | Catheter Gauge 10 Fr | Not stated | Available |
| 8888219226 | Catheter Gauge 10 Fr | Not stated | Available |
| 8888223266 | Catheter Gauge 10 Fr | Not stated | Available |
| 8888228316 | Catheter Gauge 10 Fr | Not stated | Available |
FDA clearances
- 510(k) K041006 May 2004
- 510(k) K002902 April 2001
Procedures that use tunneled dialysis catheters
Frequently asked questions
What is Tandem-Cath 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 Tandem-Cath?
Tandem-Cath is made by Mozarc Medical US LLC. It is listed under tunneled dialysis catheters (permcath) in our device library.
What sizes does Tandem-Cath come in?
Sizes listed for Tandem-Cath: Catheter Gauge: 10 Fr. Confirm availability with the manufacturer's instructions for use.
Is Tandem-Cath MRI safe?
The FDA device database entry for Tandem-Cath does not state its MRI safety status. Check the labeling before MRI.
Is Tandem-Cath FDA cleared?
Tandem-Cath is covered by FDA submissions K002902, K041006.
How do I contact a Mozarc Medical US LLC sales representative?
Mozarc Medical US LLC has not listed representatives on LA Vascular yet. Visit the Mozarc Medical US LLC 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.