78a40042-f623-4cc5-a8ae-409d8e6629e5UpdatePublished82023-09-072016-08-06In Commercial Distribution04046964315862PrimaryGS1Z-MED II X™618734618734784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1Z-MED II-X 18X5X10X8X100X.035 PDZ734falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK02272200017453Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.falseActiveDQYCATHETER, PERCUTANEOUSSpecial Storage Condition, SpecifyKeep away from sunlightSpecial Storage Condition, SpecifySpecial Storage Condition, SpecifyStore at room temptruefalse