{"publicDeviceRecordKey":"73421a91-7c90-4963-aa0f-3a0b0c708875","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2022-10-24T00:00:00.000Z","devicePublishDate":"2015-07-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840663100743","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"LeMaitre Embolectomy Catheter","versionModelNumber":"1651-84","catalogNumber":"1651-84","dunsNumber":"184805166","companyName":"Lemaitre Vascular, Inc.","deviceCount":1,"deviceDescription":"5F Plus 40CM Over-the-Wire Embolectomy Catheter\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"781-221-2266","phoneExtension":null,"email":"csus@lemaitre.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K022145","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58174","gmdnPTName":"Thrombectomy balloon catheter","gmdnPTDefinition":"A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DXE","productCodeName":"Catheter, Embolectomy"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}