Device Dossier

Indigo System Aspiration Catheter D - KIT - Embolectomy/thrombectomy suction catheter

Device Dossier for Indigo System Aspiration Catheter D - KIT - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter,…

Intended purpose

The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical thrombectomy.

Functional description

The Aspiration Catheter is inserted through a guide catheter or long femoral sheath. Once in place, the Aspiration Catheter provides a conduit to remove thrombus using the size-matched Separator. The Aspiration Tubing connects the Aspiration Catheters to the Penumbra Aspiration Pump. The Indigo System Aspiration Catheter D – KIT includes an Aspiration Catheter D, optional Catheter Accessories (Rotating Hemostasis Valve (RHV) and Introducer), and Aspiration Tubing.

TGA Public Summary