4acee9e2-0c59-4e2f-8645-56aa55865d6aUpdatePublished62022-11-022016-09-232021-08-04Not in Commercial Distribution04046964555060PrimaryGS1TYSHAK®610661610661784259751B BRAUN INTERVENTIONAL SYSTEMS, INC1PDC144 SPECIAL BALLOON CATH 16MM 6CMfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse+1(877)836-2228GUDID.BBMUS_Service@bbraun.comK931009000K99197700017184Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.falseActiveLITCatheter, angioplasty, peripheral, transluminalDevice Size Text, specifyLength : 60.000 MMDevice Size Text, specifyDiameter (mm) : 16.000 MMSpecial Storage Condition, SpecifyROOM TEMP DARK DRY PLACESpecial Storage Condition, Specifytruefalse