Device Dossier
Indigo System CAT RX KIT - Embolectomy/thrombectomy suction catheter
Device Dossier for Indigo System CAT RX KIT - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump.
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 the thrombus using the size-matched Separator. As part of the INDIGO™ Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.