82470d5a-3414-46d4-8d29-08f1a55e6713UpdatePublished42019-08-092016-08-26In Commercial Distribution04540778161351PrimaryGS1CROSSTELLA OTWBD-F40200MWBD-F40200MW690535406KANEKA CORPORATION1CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 mm). falsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse800-888-3786tmccustomer.admin@terumomedical.comK16000400017184Peripheral 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, specifyMaximum Guidewire Diameter; 0.018 inchDevice Size Text, specifyCompatible Sheath Diameter; 4 FrDevice Size Text, specifyRated Burst Pressure; 14 atmDevice Size Text, specifyNominal Pressure; 8 atmDevice Size Text, specifyShaft Diameter; 3.9 FrDevice Size Text, specifyCatheter Working Length; 900 mmDevice Size Text, specifyBalloon Length; 200 mmDevice Size Text, specifyBalloon Diameter; 4.0 mmSpecial Storage Condition, SpecifyStore in a cool, dry, dark place. Avoid exposure to water, direct sunlight.truefalse