Device Dossier
Export AP - Catheter, embolectomy
Device Dossier for Export AP - Catheter, embolectomy (Embolectomy/thrombectomy suction catheter, Class III, sponsor Medtronic). ARTG record, intended…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
The Export AP aspiration catheter’s intended purpose is to perform aspiration and containment of soft thrombo-embolic material during nonroutine percutaneous transluminal angioplasty (PTA) or stenting procedures in coronary arteries, with the effect of improving perfusion. The aspiration catheter is also intended to improve perfusion by selectively infusing and delivering diagnostic or therapeutic agents to the desired vasculature site during PTA or stenting procedures.
Functional description
The Export AP aspiration catheter is a single operator design, dual lumen catheter, compatible with 0.36mm guidewires and min 6Fr guide catheter (1.78mm min ID). It has a distal radiopaque tip marker, proximal luer-lock port, and preloaded stiffening stylet (as applicable). The proximal luer-lock port is used to connect the aspiration line and the aspiration syringe. Also, an appropriately sized syringe filled with an infusate may be attached to the aspiration line for infusing fluids.