6995767d-b449-468e-b91e-a2f7786bdc10UpdatePublished42019-08-092016-08-26In Commercial Distribution04540778152014PrimaryGS1METACROSS RXBD-L60200MRBD-L60200MR690535406KANEKA CORPORATION1METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm). falsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse800-888-3786tmccustomer.admin@terumomedical.comK15086500017184Peripheral 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.falseActiveDQYCatheter, PercutaneousDevice Size Text, specifyMaximum Guidewire Diameter; 0.035 inchDevice Size Text, specifyCompatible Sheath Diameter; 6 FrDevice Size Text, specifyRated Burst Pressure; 14 atmDevice Size Text, specifyNominal Pressure; 8 atmDevice Size Text, specifyProximal Shaft Diameter; 3.9 FrDevice Size Text, specifyDistal Shaft Diameter; 5.7 FrDevice Size Text, specifyCatheter Working Length; 900 mmDevice Size Text, specifyBalloon Length; 200 mmDevice Size Text, specifyBalloon Diameter; 6.0 mmSpecial Storage Condition, SpecifyStore in a cool, dry, dark place. Avoid exposure to water, direct sunlight.truefalse