1f17399b-377f-44be-9b0a-ac771103acd9UpdatePublished52023-09-072016-08-09In Commercial Distribution04046964329258PrimaryGS1Z-MEDâ„¢610483610483784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1PDZ333 Z-MED 14X3X100falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK122012000K99197700017453Cardiac 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.falseActiveOZTBalloon aortic valvuloplastyLITCatheter, angioplasty, peripheral, transluminalSpecial Storage Condition, SpecifySpecial Storage Condition, SpecifyStore at room tempSpecial Storage Condition, SpecifyKeep away from sunlighttruefalse