[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MCI":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":99,"syncDates":100,"translation":107,"marketSummary":113,"recalls":128,"k510s":130,"pmas":132},{"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":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":24,"event_count":25},4025,"MCI","Graft, Vascular, Hemodialysis Access, Synthetic\u002FBiological Composite","3","","Unknown","OB","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":11,"gmp_exempt_flag":18,"third_party_flag":18,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":18,"medical_specialty_description":10,"summary_malfunction_reporting":19},{"pma_number":16},[17],"P800064","N","Ineligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:48.493322+00:00",0,null,1,21,[],[28,36,43,51,57,64,71,79,86,93],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":22,"vector_similarity":34,"score":35},1091,"ウシ由来弁付人工血管","Ⅳ","46422014",0.179775,0.701431,0.0300769,{"medical_device_id":37,"generic_name":38,"class_classification":31,"jmdn_code":39,"name_similarity":40,"definition_similarity":22,"vector_similarity":41,"score":42},218,"ヘパリン使用人工血管","35093404",0.188235,0.689471,0.0293865,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":22,"vector_similarity":49,"score":50},691,"人工腎臓装置","Ⅲ","34995000",0.211268,0.684864,0.0290517,{"medical_device_id":52,"generic_name":53,"class_classification":46,"jmdn_code":54,"name_similarity":33,"definition_similarity":22,"vector_similarity":55,"score":56},765,"ヘパリン使用透析用血液回路セット","34999203",0.689877,0.0288501,{"medical_device_id":58,"generic_name":59,"class_classification":31,"jmdn_code":60,"name_similarity":61,"definition_similarity":22,"vector_similarity":62,"score":63},217,"アルブミン使用人工血管","35093304",0.166667,0.706145,0.0286935,{"medical_device_id":65,"generic_name":66,"class_classification":46,"jmdn_code":67,"name_similarity":68,"definition_similarity":22,"vector_similarity":69,"score":70},428,"植込み型血液透析用カテーテル","37278000",0.16092,0.703768,0.0275298,{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":22,"vector_similarity":77,"score":78},3917,"人工血管用サイザ","Ⅰ","70490000",0.172414,0.691146,0.0274024,{"medical_device_id":80,"generic_name":81,"class_classification":31,"jmdn_code":82,"name_similarity":83,"definition_similarity":22,"vector_similarity":84,"score":85},215,"ゼラチン使用人工血管","35093104",0.164835,0.694583,0.0269439,{"medical_device_id":87,"generic_name":88,"class_classification":46,"jmdn_code":89,"name_similarity":90,"definition_similarity":22,"vector_similarity":91,"score":92},429,"閉鎖式血液透析用カテーテル","42452000",0.162791,0.685644,0.0251662,{"medical_device_id":94,"generic_name":95,"class_classification":31,"jmdn_code":96,"name_similarity":61,"definition_similarity":22,"vector_similarity":97,"score":98},159,"吸収性血管用吻合連結器","18137004",0.675653,0.0243506,[],{"510k":101,"classification":102,"enforcement":103,"event":104,"pma":105,"warning_letter":106},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":108,"definition_ja":23,"commentary_ja":109,"model_name":110,"source_hash":111,"reviewed_by":23,"reviewed_at":23,"created_at":112,"updated_at":112},"血液透析アクセス用人工血管（合成・生体複合材料製）","本品は、血液透析を行う際に血管への穿刺アクセスを確保するために用いる、合成材料と生体材料を組み合わせた複合構造の人工血管です。米国ではクラスIIIに分類されており、この分類は疾病や傷害に対して重大なリスクを伴い得る機器に適用されます。クラスIII機器は原則として市販前承認（PMA）の対象となり、製造販売に先立って有効性および安全性に関する詳細な科学的データを提出し、FDAの厳格な審査を受ける必要があります。","claude-sonnet-5","b2855509b2f0d288b18ff5608565aa994989a046b8e9a3dbb2905406af07e69a","2026-08-24T02:13:33.96397+00:00",{"product_code":6,"summary_ja":114,"stats":115,"stats_hash":126,"model_name":110,"created_at":127,"updated_at":127},"本製品はPMA（市販前承認）区分の機器で、本承認が1件あり、最新の判定は1982年3月となっています。不具合報告は累計約20件で、その大半が傷害（Injury）に関するものであり、死亡報告は確認されていません。直近5年間の不具合報告および回収は確認されておらず、最新の報告月は2006年2月です。回収についてはクラスI・II・IIIのいずれも累計0件となっています。",{"pma":116,"k510":118,"as_of":119,"events":120,"recalls":123,"top_problems":125},{"latest":117,"originals":24,"supplements":22},"1982-03-10",{"total":22,"last5y":22,"latest":23,"applicants":22},"2026-08",{"death":22,"other":22,"total":25,"injury":121,"last5y":22,"malfunction":24,"latest_month":122},20,"2006-02",{"total":22,"last5y":22,"latest":23,"class_i":22,"class_ii":22,"class_iii":22,"top_root_causes":124},[],[],"b8ff56ac8a87c3a314eb2730bb5c88912341d1bdb8ddcf5038e957c924a1e3dd","2026-08-24T04:52:46.442187+00:00",{"items":129,"total":22},[],{"items":131,"total":22},[],{"items":133,"total":24},[134],{"pma_number":17,"supplement_number":9,"trade_name":135,"applicant":136,"decision_date":117},"BIOFLOW(TM)","Genetic Laboratories, Inc."]