Device Dossier
HemoStar - Catheter, haemodialysis, implantable
Device Dossier for HemoStar - Catheter, haemodialysis, implantable (Catheter, haemodialysis, implantable, Class III, sponsor Bard). ARTG record, intended…
- GMDN category: Catheter, haemodialysis, implantable
Intended purpose
Intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein,subclavian vein, or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.
Functional description
Catheters are made of Carbothane radiopaque polyurethane and allow for flow rates as high as 500 ml/min. The catheter shaft is divided internally into two separate lumens by a septum allowing hemodialysis without the use of a ?single needle? system. The catheter comes with a white retention cuff for tissue ingrowth to anchor the catheter.