Device Dossier
Indigo System - Embolectomy/thrombectomy suction catheter
Device Dossier for Indigo System - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor Penumbra…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
The INDIGO Flash Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Lightning Flash Aspiration Tubing is a sterile aspiration tubing component of the Indigo System and is designed to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature.
Functional description
The Indigo System Lightning FLASH Kits consist of a 16F Flash Aspiration Catheter packaged together with Lightning Flash Aspiration Tubing and a Select + Catheter. The Aspiration Catheter serves as a conduit to aspirate thrombus from an occluded vessel. Lightning FLASH Aspiration Tubing utilizes software which monitors two pressure sensors along the length of the tubing to determine whether or not a solenoid valve is open or shut.