Device Dossier

Transjugular Liver Access and Biopsy Needle Set - Biopsy kit, soft tissue

Device Dossier for Transjugular Liver Access and Biopsy Needle Set - Biopsy kit, soft tissue (Biopsy kit, soft tissue, Class III, sponsor William A…

Intended purpose

These devices are Colapinto needle assemblies that are inserted via transjugular access to: 1. Create an initial intrahepatic tract between the hepatic and portal veins, through which additional diagnostic and interventional procedures can be performed; or 2. Obtain liver tissue samples by aspiration.