f0d2e0c8-648f-418c-b8ef-1b0de242507aUpdatePublished52022-11-092016-07-30In Commercial Distribution00814548010366PrimaryGS1Penumbra SystemPSS032191077671PENUMBRA, INC.1PS Separator 032falsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety InformationfalsefalseK07271800058173Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.falseActiveNRYCATHETER, THROMBUS RETRIEVERtruefalse