[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DTI":3},{"classification":4,"mappedDevices":71,"similarCandidates":72,"relatedClassifications":146,"syncDates":147},{"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":64,"updated_at":65,"recall_count":66,"latest_recall_date":67,"k510_count":68,"pma_count":69,"event_count":70},4797,"DTI","Sizer, Heart-Valve, Prosthesis","1","870.3945","CV","Cardiovascular","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":62,"product_code":6,"review_panel":10,"gmp_exempt_flag":62,"third_party_flag":62,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":62,"medical_specialty_description":11,"summary_malfunction_reporting":63},{"k_number":17,"fei_number":25,"registration_number":48},[18,19,20,21,22,23,24],"K881279","K853313","K952184","K852612","K934951","K801885","K820887",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"2015691","3002750084","3002534070","1713910","3038284086","3005334138","1720929","3007113487","2025587","3001584317","3001451326","3001236549","1000160162","3001883144","1000517719","3001286223","3005687633","3004053982","3010041511","3004521048","3010805418","3005747797",[26,49,50,30,32,51,52,33,34,53,54,55,39,56,42,57,58,44,59,60,46,61],"1646747","3008500478","2135147","1836161","1723241","1649833","3011137372","8043385","1063481","9615005","8010697","2031093","9617601","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",2,"2020-03-18",7,0,200,[],[73,81,89,95,103,110,117,125,132,139],{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":69,"vector_similarity":79,"score":80},3913,"人工心臓弁用サイザ","Ⅰ","17703010",0.621622,0.838328,0.0327869,{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":69,"vector_similarity":87,"score":88},2363,"人工弁ローテータ","Ⅱ","70483009",0.459459,0.717884,0.031498,{"medical_device_id":90,"generic_name":91,"class_classification":76,"jmdn_code":92,"name_similarity":93,"definition_similarity":69,"vector_similarity":94,"score":88},3915,"人工弁テスタ","70482000",0.514286,0.707628,{"medical_device_id":96,"generic_name":97,"class_classification":98,"jmdn_code":99,"name_similarity":100,"definition_similarity":69,"vector_similarity":101,"score":102},687,"眼弁補綴材","Ⅲ","42526000",0.515152,0.688481,0.0304147,{"medical_device_id":104,"generic_name":105,"class_classification":76,"jmdn_code":106,"name_similarity":107,"definition_similarity":69,"vector_similarity":108,"score":109},3916,"人工弁ホルダ及びハンドル","70483000",0.44186,0.698094,0.0298774,{"medical_device_id":111,"generic_name":112,"class_classification":98,"jmdn_code":113,"name_similarity":114,"definition_similarity":69,"vector_similarity":115,"score":116},423,"水頭症用バルブ補綴材","35965000",0.428571,0.662925,0.0278097,{"medical_device_id":118,"generic_name":119,"class_classification":120,"jmdn_code":121,"name_similarity":122,"definition_similarity":69,"vector_similarity":123,"score":124},198,"人工血管付ブタ心臓弁","Ⅳ","35591300",0.303571,0.700177,0.0263875,{"medical_device_id":126,"generic_name":127,"class_classification":98,"jmdn_code":128,"name_similarity":129,"definition_similarity":69,"vector_similarity":130,"score":131},633,"橈骨頭用補綴材","35966003",0.368421,0.641871,0.0258564,{"medical_device_id":133,"generic_name":134,"class_classification":76,"jmdn_code":135,"name_similarity":136,"definition_similarity":69,"vector_similarity":137,"score":138},4444,"弁形成術用サイザ","47684001",0.232558,0.755209,0.016129,{"medical_device_id":140,"generic_name":141,"class_classification":120,"jmdn_code":142,"name_similarity":143,"definition_similarity":69,"vector_similarity":144,"score":145},195,"人工血管付機械式人工心臓弁","35590020",0.283333,0.701041,0.0153846,[],{"510k":148,"classification":149,"enforcement":150,"event":151,"pma":152,"warning_letter":153},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]