[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QCT":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":115,"syncDates":116},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":15,"raw":16,"created_at":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":34,"event_count":35},4958,"QCT","Scaffold, Dissection Repair","3","","Unknown","CV","2","For the repair of dissections following percutaneous transluminal angioplasty in the lower extremity arteries",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":11,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":26,"medical_specialty_description":10,"summary_malfunction_reporting":28},{"fei_number":18,"pma_number":21,"registration_number":24},[19,20],"1928237","3003565456",[22,23],"P180034","P190027",[19,25],"9710641","Y","N","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",1,"2025-02-26",0,14,478,[],[38,47,56,64,72,80,87,93,100,108],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},4290,"切開器","Ⅰ","11290000",0.233333,0.118243,0.61015,0.0281581,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},85,"アテローム切除型血管形成術用カテーテル","Ⅳ","17519000",0.0178571,0.229437,0.702312,0.0163934,{"medical_device_id":57,"generic_name":58,"class_classification":50,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},93,"アテローム切除アブレーション式血管形成術用カテーテル","36073000",0.015625,0.188,0.680342,0.016129,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":63},2733,"義歯補修キット","Ⅱ","11171000",0.210526,0.120603,0.466162,{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":33,"definition_similarity":77,"vector_similarity":78,"score":79},920,"エキシマレーザ血管形成器","Ⅲ","70637000",0.270408,0.647669,0.015873,{"medical_device_id":81,"generic_name":82,"class_classification":41,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":79},4204,"再使用可能な切除用刃","35836000",0.190476,0.148571,0.593139,{"medical_device_id":88,"generic_name":89,"class_classification":50,"jmdn_code":90,"name_similarity":33,"definition_similarity":91,"vector_similarity":92,"score":60},83,"レーザ式血管形成術用カテーテル","17185000",0.126829,0.646991,{"medical_device_id":94,"generic_name":95,"class_classification":67,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":60},2769,"歯科用セラミック補修キット","35877000",0.177778,0.167401,0.485383,{"medical_device_id":101,"generic_name":102,"class_classification":50,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},1086,"薬剤溶出型大腿動脈用ステント","46919004",0.0322581,0.140673,0.64574,0.0153846,{"medical_device_id":109,"generic_name":110,"class_classification":41,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":107},3457,"レゼクトスコープ用吸引器","37143000",0.183673,0.103053,0.4774,[],{"510k":117,"classification":118,"enforcement":119,"event":120,"pma":121,"warning_letter":122},"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","2026-08-18T06:42:29.411+00:00"]