[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NIF":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":112,"syncDates":220,"translation":227,"marketSummary":234,"recalls":247,"k510s":249,"pmas":251},{"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":15,"raw":16,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":24,"pma_count":24,"event_count":26},5279,"NIF","Catheter, Hemodialysis, Triple Lumen, Implanted","2","876.5540","GU","Gastroenterology, Urology","1","Long-term (> 30 days) central venous access for hemodialysis, and apheresis, with a third lumen for infusion.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":18,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":18,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":21},{},"","Y","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:49.169481+00:00",0,null,7,[],[29,38,47,55,64,72,80,88,96,104],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":35,"vector_similarity":36,"score":37},428,"植込み型血液透析用カテーテル","Ⅲ","37278000",0.538462,0.196774,0.794573,0.0327869,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},2075,"血液透析用シングルニードル付カテーテル","Ⅱ","34922000",0.323077,0.239726,0.746997,0.0315136,{"medical_device_id":48,"generic_name":49,"class_classification":32,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},429,"閉鎖式血液透析用カテーテル","42452000",0.385965,0.2,0.719979,0.0310544,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},142,"体内植込み用カテーテル","Ⅳ","70384000",0.346939,0.151961,0.706582,0.0297095,{"medical_device_id":65,"generic_name":66,"class_classification":41,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},2047,"単回使用マルチルーメンカテーテル","32330102",0.262295,0.133047,0.731266,0.0290832,{"medical_device_id":73,"generic_name":74,"class_classification":58,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},143,"ヘパリン使用体内植込み用カテーテル","70385000",0.355932,0.15566,0.686069,0.028373,{"medical_device_id":81,"generic_name":82,"class_classification":58,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},118,"中心循環系マルチルーメンカテーテル","32330324",0.217391,0.175,0.739876,0.0279212,{"medical_device_id":89,"generic_name":90,"class_classification":32,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},426,"血液透析用コアキシャルフロー型カテーテルイントロデューサキット","33799100",0.263889,0.265823,0.697331,0.0278638,{"medical_device_id":97,"generic_name":98,"class_classification":58,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},144,"ウロキナーゼ使用体内植込み用カテーテル","70386000",0.265625,0.166667,0.702863,0.0277778,{"medical_device_id":105,"generic_name":106,"class_classification":32,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},691,"人工腎臓装置","34995000",0.25,0.205128,0.702434,0.0272121,[113,117,121,125,129,133,137,141,145,149,153,157,160,164,167,170,174,177,181,184,187,190,193,196,199,202,205,208,211,214,217],{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"MSD","Catheter, Hemodialysis, Implanted",124,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"FIE","Needle, Fistula",80,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"LFJ","Catheter, Subclavian",65,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"MPB","Catheter, Hemodialysis, Non-Implanted",38,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"FIQ","Cannula, A-V Shunt",23,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"LFK","Catheter, Femoral",16,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"NIE","Catheter, Hemodialysis, Triple Lumen, Non-Implanted",12,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"NFK","Kit, Repair, Catheter, Hemodialysis",11,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"KNZ","Accessories, A-V Shunt",10,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"LBW","Set, Dialysis, Single Needle (Co-Axial Flow)",5,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"FKN","Adaptor, Shunt",4,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"NQJ","Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use",{"product_code":161,"device_name":162,"device_class":12,"k510_count":163},"FJQ","Connector, Shunt",3,{"product_code":165,"device_name":166,"device_class":8,"k510_count":163},"FKA","Dilator, Vessel",{"product_code":168,"device_name":169,"device_class":8,"k510_count":163},"FKW","Tip, Vessel",{"product_code":171,"device_name":172,"device_class":8,"k510_count":173},"NYU","Catheter, Hemodialysis, Implanted, Coated",2,{"product_code":175,"device_name":176,"device_class":8,"k510_count":173},"PEH","Hemodialysis Catheter Luer End Cap",{"product_code":178,"device_name":179,"device_class":12,"k510_count":180},"FKC","Clamp, Cannula",1,{"product_code":182,"device_name":183,"device_class":8,"k510_count":180},"KNR","Adapter, A-V Shunt Or Fistula",{"product_code":185,"device_name":186,"device_class":8,"k510_count":180},"PFH","Venous Window Needle Guide",{"product_code":188,"device_name":189,"device_class":8,"k510_count":24},"FJM","Guard, Shunt",{"product_code":191,"device_name":192,"device_class":8,"k510_count":24},"FJN","Stabilizer, Shunt",{"product_code":194,"device_name":195,"device_class":12,"k510_count":24},"FJO","Plier, Tube",{"product_code":197,"device_name":198,"device_class":12,"k510_count":24},"FJR","Forceps, Disconnect",{"product_code":200,"device_name":201,"device_class":12,"k510_count":24},"FJW","Ring, Joint",{"product_code":203,"device_name":204,"device_class":12,"k510_count":24},"FJX","Ring, Crimp",{"product_code":206,"device_name":207,"device_class":12,"k510_count":24},"FJY","Plier, Crimp",{"product_code":209,"device_name":210,"device_class":8,"k510_count":24},"NNE","Needle, Fistula, Reprocessed",{"product_code":212,"device_name":213,"device_class":12,"k510_count":24},"NOO","Clamp, Dialysis Arm",{"product_code":215,"device_name":216,"device_class":8,"k510_count":24},"PKI","Fully Subcutaneous Implanted Hemodialysis Catheter",{"product_code":218,"device_name":219,"device_class":8,"k510_count":24},"PPO","Multi-Lumen Hemodialysis Catheterization Kit",{"510k":221,"classification":222,"enforcement":223,"event":224,"pma":225,"warning_letter":226},"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":228,"definition_ja":229,"commentary_ja":230,"model_name":231,"source_hash":232,"reviewed_by":25,"reviewed_at":25,"created_at":233,"updated_at":233},"植込み型三腔血液透析カテーテル","血液透析及びアフェレーシスのための長期（30日超）中心静脈アクセスであり、輸液用の第三のルーメンを備えるものである。","本機器は米国FDAの規制上クラスIIに分類されており、市販前届出（510(k)）の対象となっています。510(k)は、既存の合法的に販売されている類似機器（既存同等機器）と実質的に同等であることを示すことにより市販が認められる審査区分であり、クラスIIIに適用される市販前承認（PMA）に比べて簡易な手続きとなっています。","claude-sonnet-5","09b528a2e7b0b4831881b245b7bb10bbf8c78237720b23fcc17ebe9924e0957b","2026-08-24T02:18:13.311568+00:00",{"product_code":6,"summary_ja":235,"stats":236,"stats_hash":245,"model_name":231,"created_at":246,"updated_at":246},"本製品コードについては、510(k)の届出および回収の記録は確認されていません。不具合報告は累計約7件で、いずれも死亡・傷害ではなく不具合（Malfunction）に分類されています。直近5年間の報告はなく、最新の報告月は2018年9月となっています。",{"pma":237,"k510":238,"as_of":239,"events":240,"recalls":242,"top_problems":244},{"latest":25,"originals":24,"supplements":24},{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":24,"other":24,"total":26,"injury":24,"last5y":24,"malfunction":26,"latest_month":241},"2018-09",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":243},[],[],"c626db5483bed9c49a007ec0fa6c49ccccfab423be0d44ac22e271e339ca7972","2026-08-24T04:59:09.208125+00:00",{"items":248,"total":24},[],{"items":250,"total":24},[],{"items":252,"total":24},[]]