{"publicDeviceRecordKey":"c71d0fff-2e83-41a2-b447-f69a62ad4194","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-10-07T00:00:00.000Z","devicePublishDate":"2017-06-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04540778167698","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"RX TAKERU","versionModelNumber":"DC-RY2212UA2","catalogNumber":"DC-RY2212UA2","dunsNumber":"690535406","companyName":"KANEKA CORPORATION","deviceCount":1,"deviceDescription":"RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm). ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-888-3786","phoneExtension":null,"email":"tmccustomer.admin@terumomedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K163372","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47732","gmdnPTName":"Coronary angioplasty balloon catheter, basic","gmdnPTDefinition":"A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LOX","productCodeName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Maximum Guidewire Diameter; 0.014 inch"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Compatible Guiding Catheter; 5 Fr"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Rated Burst Pressure; 14 atm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Nominal Pressure; 6 atm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Proximal Shaft Diameter; 2.0 Fr"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Distal Shaft Diameter; 2.5 Fr"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Catheter Working Length; 1450 mm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Balloon Length; 12 mm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Balloon Diameter; 2.25 mm"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}