21d8b050-73c1-4175-93d2-3d2f6f7eec80UpdatePublished82023-09-072016-08-09In Commercial Distribution04046964511936PrimaryGS1TYSHAK NuCLEUS™612112612112784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1TN035 TYSHAK NUCLEUS 22X4X100falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK12185900017453Cardiac 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, SpecifySpecial Storage Condition, SpecifyStore at room tempSpecial Storage Condition, SpecifyKeep away from sunlightSpecial Storage Condition, SpecifyKEEP DRYtruefalse