8e24e00b-d54c-411b-8981-3dcbb036fff5UpdatePublished42019-08-092016-08-26In Commercial Distribution04540778158894PrimaryGS1CROSSTELLA RXBD-F20080LRBD-F20080LR690535406KANEKA CORPORATION1CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm). falsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse800-888-3786tmccustomer.admin@terumomedical.comK15287300017184Peripheral 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, specifyProximal Shaft Diameter; 3.4 FrDevice Size Text, specifyDistal Shaft Diameter; 4.0 FrDevice Size Text, specifyCatheter Working Length; 1500 mmDevice Size Text, specifyBalloon Length; 80 mmDevice Size Text, specifyBalloon Diameter; 2.0 mmSpecial Storage Condition, SpecifyStore in a cool, dry, dark place. Avoid exposure to water, direct sunlight.truefalse