[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QEY":3},{"classification":4,"mappedDevices":128,"similarCandidates":129,"relatedClassifications":212,"syncDates":233},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":121,"updated_at":122,"recall_count":123,"latest_recall_date":124,"k510_count":125,"pma_count":126,"event_count":127},1854,"QEY","Mechanical Thrombolysis Catheter","2","870.5150","CV","Cardiovascular","1","To mechanically disrupt thrombus and\u002For debris in the peripheral vasculature.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":118,"device_class":8,"implant_flag":119,"product_code":6,"review_panel":10,"gmp_exempt_flag":119,"third_party_flag":119,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":118,"life_sustain_support_flag":119,"medical_specialty_description":11,"summary_malfunction_reporting":120},{"k_number":17,"fei_number":89,"registration_number":113},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"K972110","K083335","K023514","K072507","K062507","K052428","K182324","K211080","K251318","K060422","K202347","K052071","K082199","K260149","K153488","K974067","K032261","K041629","K231653","K950615","K952317","K191119","K033443","K200648","K043269","K992231","K111705","K050147","K030637","K041705","K222095","K021958","K241851","K042456","K081467","K162777","K041517","K151554","K211061","K951509","K130904","K063620","K961763","K162771","K163356","K981417","K050563","K080392","K972175","K013635","K980957","K991619","K970842","K183361","K183290","K071664","K071762","K953384","K071933","K192598","K950907","K193071","K051319","K170258","K220866","K060084","K140151","K053432","K033214","K213422","K192864",[90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112],"3033589330","3015225571","3000335778","1000121056","3038791046","1319211","3002095335","3002807314","3006950086","3010273872","3003094851","1000523114","3007695959","3027595864","3012536737","2124215","3015309643","2246552","3002806565","3015489145","1721504","3003678543","1721676",[90,91,93,94,114,95,115,97,116,98,99,101,102,117,103,104,105,106,107,109,110,111,112],"2134265","1724474","9681260","9616662","","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",4,"2024-01-10",71,0,27,[],[130,139,147,156,164,172,180,188,196,204],{"medical_device_id":131,"generic_name":132,"class_classification":133,"jmdn_code":134,"name_similarity":135,"definition_similarity":136,"vector_similarity":137,"score":138},78,"脳血栓破砕用バイブレーションカテーテル","Ⅳ","70284000",0.285714,0.224599,0.782911,0.0322665,{"medical_device_id":140,"generic_name":141,"class_classification":133,"jmdn_code":142,"name_similarity":143,"definition_similarity":144,"vector_similarity":145,"score":146},77,"中心循環系血栓破砕用バイブレーションカテーテル","70283000",0.238806,0.208531,0.793978,0.0306792,{"medical_device_id":148,"generic_name":149,"class_classification":150,"jmdn_code":151,"name_similarity":152,"definition_similarity":153,"vector_similarity":154,"score":155},396,"非中心循環系血栓破砕用バイブレーションカテーテル","Ⅲ","70282000",0.228571,0.186047,0.788055,0.0281772,{"medical_device_id":157,"generic_name":158,"class_classification":150,"jmdn_code":159,"name_similarity":160,"definition_similarity":161,"vector_similarity":162,"score":163},428,"植込み型血液透析用カテーテル","37278000",0.236364,0.165563,0.72082,0.0268759,{"medical_device_id":165,"generic_name":166,"class_classification":150,"jmdn_code":167,"name_similarity":168,"definition_similarity":169,"vector_similarity":170,"score":171},429,"閉鎖式血液透析用カテーテル","42452000",0.240741,0.0719424,0.705609,0.0231407,{"medical_device_id":173,"generic_name":174,"class_classification":150,"jmdn_code":175,"name_similarity":176,"definition_similarity":177,"vector_similarity":178,"score":179},406,"マイクロダイアリシスカテーテル","70297000",0.304348,0.0979381,0.693249,0.016129,{"medical_device_id":181,"generic_name":182,"class_classification":150,"jmdn_code":183,"name_similarity":184,"definition_similarity":185,"vector_similarity":186,"score":187},821,"腹膜透析用カテーテル","34921000",0.291667,0.102902,0.694976,0.015873,{"medical_device_id":189,"generic_name":190,"class_classification":133,"jmdn_code":191,"name_similarity":192,"definition_similarity":193,"vector_similarity":194,"score":195},1077,"振動式末梢血管貫通用カテーテルシステム","46850004",0.135135,0.173077,0.757718,0.015625,{"medical_device_id":197,"generic_name":198,"class_classification":199,"jmdn_code":200,"name_similarity":201,"definition_similarity":202,"vector_similarity":203,"score":195},3544,"血栓分析装置","Ⅰ","36746000",0.261905,0.17284,0.62856,{"medical_device_id":205,"generic_name":206,"class_classification":133,"jmdn_code":207,"name_similarity":208,"definition_similarity":209,"vector_similarity":210,"score":211},76,"中心循環系塞栓除去用カテーテル","10714004",0.1875,0.120833,0.754277,0.0153846,[213,217,221,225,229],{"product_code":214,"device_name":215,"device_class":8,"k510_count":216},"QEW","Peripheral Mechanical Thrombectomy With Aspiration",142,{"product_code":218,"device_name":219,"device_class":8,"k510_count":220},"QEZ","Aspiration Thrombectomy Catheter",94,{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"DXE","Catheter, Embolectomy",74,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"MMX","Device, Percutaneous Retrieval",32,{"product_code":230,"device_name":231,"device_class":8,"k510_count":232},"QEX","Coronary Mechanical Thrombectomy With Aspiration",3,{"510k":234,"classification":235,"enforcement":236,"event":237,"pma":238,"warning_letter":239},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]