ada9ad1d-32e9-4881-91ec-ed3241552264UpdatePublished52022-11-022016-08-092021-08-04Not in Commercial Distribution04046964328640PrimaryGS1Z-MEDâ„¢610451610451784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1PDZ301 SPECIAL Z-MED 5X2X85falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling 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.falseActiveLITCatheter, angioplasty, peripheral, transluminalOZTBalloon aortic valvuloplastySpecial Storage Condition, SpecifyROOM TEMP AWAY FROM SUNLIGHTSpecial Storage Condition, Specifytruefalse