{"publicDeviceRecordKey":"e1e848e6-eca6-4f2c-9eb8-cd4e0a125cb2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-08-13T00:00:00.000Z","devicePublishDate":"2016-04-07T00:00:00.000Z","deviceCommDistributionEndDate":"2025-08-11T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00847536020719","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SolitiareTM","versionModelNumber":"SFR2-4-20","catalogNumber":null,"dunsNumber":"826110710","companyName":"Micro Therapeutics, Inc.","deviceCount":1,"deviceDescription":"STENT SFR2-4-20 V01 US","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K123378","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58173","gmdnPTName":"Thrombectomy suction catheter","gmdnPTDefinition":"A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NRY","productCodeName":"CATHETER, THROMBUS RETRIEVER"},{"productCode":"POL","productCodeName":"Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a dry, cool place"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}