Device Dossier

Indigo System Aspiration Catheter Kit - Embolectomy/thrombectomy suction catheter

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

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 KIT includes an Aspiration Catheter, optional Catheter Accessories (Rotating Hemostasis Valve (RHV) and Introducer), and Aspiration Tubing.

TGA Public Summary