[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NFK":3},{"classification":4,"mappedDevices":67,"similarCandidates":68,"relatedClassifications":150,"syncDates":256},{"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":15,"gmp_exempt_flag":14,"raw":16,"created_at":60,"updated_at":61,"recall_count":62,"latest_recall_date":63,"k510_count":64,"pma_count":65,"event_count":66},4969,"NFK","Kit, Repair, Catheter, Hemodialysis","2","876.5540","GU","Gastroenterology, Urology","1","Hemodialysis Tray",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":56,"device_class":8,"implant_flag":57,"product_code":6,"review_panel":10,"gmp_exempt_flag":57,"third_party_flag":57,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":56,"life_sustain_support_flag":58,"medical_specialty_description":11,"summary_malfunction_reporting":59},{"k_number":18,"fei_number":30,"registration_number":48},[19,20,21,22,23,24,25,26,27,28,29],"K020430","K092797","K022644","K062435","K063446","K101261","K011576","K022570","K030442","K011015","K022561",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"2518902","3006082230","3015859709","3030574705","1282497","1000512168","3010041511","3000206435","1000138054","3003915875","3002807391","1000306216","3003737899","1018233","3009211636","3002468371","3006260740",[49,47,32,50,31,33,34,35,37,40,51,52,44,45,53,54,55],"1722746","9617592","9680794","2030624","1319639","9610849","1061124","","N","Y","Ineligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",12,"2020-08-19",11,0,138,[],[69,78,86,94,101,110,118,125,133,141],{"medical_device_id":70,"generic_name":71,"class_classification":72,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},428,"植込み型血液透析用カテーテル","Ⅲ","37278000",0.416667,0.0531915,0.725304,0.031746,{"medical_device_id":79,"generic_name":80,"class_classification":72,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},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",0.410714,0.125,0.713356,0.0308349,{"medical_device_id":87,"generic_name":88,"class_classification":72,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":93},429,"閉鎖式血液透析用カテーテル","42452000",0.425532,0.175,0.705482,0.0306792,{"medical_device_id":95,"generic_name":96,"class_classification":72,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":93},691,"人工腎臓装置","34995000",0.325,0.264151,0.731815,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},2075,"血液透析用シングルニードル付カテーテル","Ⅱ","34922000",0.37037,0.150538,0.706732,0.0298774,{"medical_device_id":111,"generic_name":112,"class_classification":72,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":117},427,"ウロキナーゼ使用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","33799200",0.367647,0.112,0.703025,0.029236,{"medical_device_id":119,"generic_name":120,"class_classification":72,"jmdn_code":121,"name_similarity":122,"definition_similarity":123,"vector_similarity":124,"score":117},823,"腹膜灌流用カテーテルイントロデューサキット","16992000",0.358491,0.0114943,0.714887,{"medical_device_id":126,"generic_name":127,"class_classification":72,"jmdn_code":128,"name_similarity":129,"definition_similarity":130,"vector_similarity":131,"score":132},406,"マイクロダイアリシスカテーテル","70297000",0.395349,0.0604027,0.684679,0.0282832,{"medical_device_id":134,"generic_name":135,"class_classification":104,"jmdn_code":136,"name_similarity":137,"definition_similarity":138,"vector_similarity":139,"score":140},2733,"義歯補修キット","11171000",0.268293,0.00714286,0.713918,0.0269736,{"medical_device_id":142,"generic_name":143,"class_classification":144,"jmdn_code":145,"name_similarity":146,"definition_similarity":147,"vector_similarity":148,"score":149},3690,"一時的使用カテーテルバルーン補修キット","Ⅰ","31665001",0.363636,0.00943396,0.683487,0.0268384,[151,155,159,163,167,171,175,178,182,186,190,193,197,200,203,207,210,214,217,220,223,226,229,232,235,238,241,244,247,250,253],{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"MSD","Catheter, Hemodialysis, Implanted",124,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"FIE","Needle, Fistula",80,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"LFJ","Catheter, Subclavian",65,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"MPB","Catheter, Hemodialysis, Non-Implanted",38,{"product_code":168,"device_name":169,"device_class":8,"k510_count":170},"FIQ","Cannula, A-V Shunt",23,{"product_code":172,"device_name":173,"device_class":8,"k510_count":174},"LFK","Catheter, Femoral",16,{"product_code":176,"device_name":177,"device_class":8,"k510_count":62},"NIE","Catheter, Hemodialysis, Triple Lumen, Non-Implanted",{"product_code":179,"device_name":180,"device_class":8,"k510_count":181},"KNZ","Accessories, A-V Shunt",10,{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"LBW","Set, Dialysis, Single Needle (Co-Axial Flow)",5,{"product_code":187,"device_name":188,"device_class":8,"k510_count":189},"FKN","Adaptor, Shunt",4,{"product_code":191,"device_name":192,"device_class":8,"k510_count":189},"NQJ","Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use",{"product_code":194,"device_name":195,"device_class":12,"k510_count":196},"FJQ","Connector, Shunt",3,{"product_code":198,"device_name":199,"device_class":8,"k510_count":196},"FKA","Dilator, Vessel",{"product_code":201,"device_name":202,"device_class":8,"k510_count":196},"FKW","Tip, Vessel",{"product_code":204,"device_name":205,"device_class":8,"k510_count":206},"NYU","Catheter, Hemodialysis, Implanted, Coated",2,{"product_code":208,"device_name":209,"device_class":8,"k510_count":206},"PEH","Hemodialysis Catheter Luer End Cap",{"product_code":211,"device_name":212,"device_class":12,"k510_count":213},"FKC","Clamp, Cannula",1,{"product_code":215,"device_name":216,"device_class":8,"k510_count":213},"KNR","Adapter, A-V Shunt Or Fistula",{"product_code":218,"device_name":219,"device_class":8,"k510_count":213},"PFH","Venous Window Needle Guide",{"product_code":221,"device_name":222,"device_class":8,"k510_count":65},"FJM","Guard, Shunt",{"product_code":224,"device_name":225,"device_class":8,"k510_count":65},"FJN","Stabilizer, Shunt",{"product_code":227,"device_name":228,"device_class":12,"k510_count":65},"FJO","Plier, Tube",{"product_code":230,"device_name":231,"device_class":12,"k510_count":65},"FJR","Forceps, Disconnect",{"product_code":233,"device_name":234,"device_class":12,"k510_count":65},"FJW","Ring, Joint",{"product_code":236,"device_name":237,"device_class":12,"k510_count":65},"FJX","Ring, Crimp",{"product_code":239,"device_name":240,"device_class":12,"k510_count":65},"FJY","Plier, Crimp",{"product_code":242,"device_name":243,"device_class":8,"k510_count":65},"NIF","Catheter, Hemodialysis, Triple Lumen, Implanted",{"product_code":245,"device_name":246,"device_class":8,"k510_count":65},"NNE","Needle, Fistula, Reprocessed",{"product_code":248,"device_name":249,"device_class":12,"k510_count":65},"NOO","Clamp, Dialysis Arm",{"product_code":251,"device_name":252,"device_class":8,"k510_count":65},"PKI","Fully Subcutaneous Implanted Hemodialysis Catheter",{"product_code":254,"device_name":255,"device_class":8,"k510_count":65},"PPO","Multi-Lumen Hemodialysis Catheterization Kit",{"510k":257,"classification":258,"enforcement":259,"event":260,"pma":261,"warning_letter":262},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]