[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FJT":3},{"classification":4,"mappedDevices":33,"similarCandidates":34,"relatedClassifications":107,"syncDates":315,"translation":322,"marketSummary":328,"recalls":342,"k510s":344,"pmas":364},{"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":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":32},4864,"FJT","Intracatheter, Dialysis","2","876.5820","GU","Gastroenterology, Urology","1","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":18},[19,20,21,22,23],"K772146","K760781","K863297","K772148","K770047","N","Y","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:47.656965+00:00",0,null,5,8,[],[35,43,50,57,65,71,79,86,93,100],{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":29,"vector_similarity":41,"score":42},821,"腹膜透析用カテーテル","Ⅲ","34921000",0.444444,0.782789,0.0327869,{"medical_device_id":44,"generic_name":45,"class_classification":38,"jmdn_code":46,"name_similarity":47,"definition_similarity":29,"vector_similarity":48,"score":49},406,"マイクロダイアリシスカテーテル","70297000",0.388889,0.748159,0.031746,{"medical_device_id":51,"generic_name":52,"class_classification":38,"jmdn_code":53,"name_similarity":54,"definition_similarity":29,"vector_similarity":55,"score":56},428,"植込み型血液透析用カテーテル","37278000",0.348837,0.732433,0.0303309,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":29,"vector_similarity":63,"score":64},137,"髄腔内カテーテル","Ⅳ","70336000",0.4,0.716825,0.0302135,{"medical_device_id":66,"generic_name":67,"class_classification":38,"jmdn_code":68,"name_similarity":69,"definition_similarity":29,"vector_similarity":70,"score":64},429,"閉鎖式血液透析用カテーテル","42452000",0.325581,0.751129,{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":29,"vector_similarity":77,"score":78},2101,"子宮用カテーテル","Ⅱ","16431000",0.375,0.71025,0.0287829,{"medical_device_id":80,"generic_name":81,"class_classification":74,"jmdn_code":82,"name_similarity":83,"definition_similarity":29,"vector_similarity":84,"score":85},2067,"注入用カテーテル","33172000",0.28125,0.725827,0.027972,{"medical_device_id":87,"generic_name":88,"class_classification":74,"jmdn_code":89,"name_similarity":90,"definition_similarity":29,"vector_similarity":91,"score":92},1854,"透析用留置針","70204030",0.282051,0.720704,0.0276929,{"medical_device_id":94,"generic_name":95,"class_classification":38,"jmdn_code":96,"name_similarity":97,"definition_similarity":29,"vector_similarity":98,"score":99},823,"腹膜灌流用カテーテルイントロデューサキット","16992000",0.319149,0.713469,0.027032,{"medical_device_id":101,"generic_name":102,"class_classification":38,"jmdn_code":103,"name_similarity":104,"definition_similarity":29,"vector_similarity":105,"score":106},825,"腹膜灌流用カテーテルアダプタ","35944000",0.363636,0.694345,0.0270125,[108,112,116,120,124,128,132,136,140,144,148,151,155,159,162,165,168,172,175,179,182,185,188,191,194,197,201,204,207,210,213,216,220,223,226,229,232,236,239,243,246,249,252,255,258,261,264,267,270,273,276,279,282,285,288,291,294,297,300,303,306,309,312],{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"KOC","Accessories, Blood Circuit, Hemodialysis",182,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"FJI","Dialyzer, Capillary, Hollow Fiber",131,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"LIF","Dialyzer Reprocessing System",57,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"FKP","System, Dialysate Delivery, Single Patient",50,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"FJG","Dialyzer, Parallel Flow",36,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"FIB","Protector, Transducer, Dialysis",35,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"FIN","Tank, Holding, Dialysis",18,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"MQS","System, Hemodialysis, Access Recirculation Monitoring",{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"FIZ","Meter, Conductivity, Non-Remote",13,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"FHS","Dialyzer, Single Coil",12,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"FKR","Subsystem, Proportioning",{"product_code":163,"device_name":164,"device_class":8,"k510_count":32},"FIL","System, Dialysate Delivery, Single Pass",{"product_code":166,"device_name":167,"device_class":8,"k510_count":32},"FKH","Solution-Test Standard-Conductivity, Dialysis",{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"FIR","Pump, Blood, Extra-Luminal",7,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"MSE","Hemodialyzer, Re-Use, Low Flux",{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,{"product_code":180,"device_name":181,"device_class":12,"k510_count":178},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis",{"product_code":183,"device_name":184,"device_class":8,"k510_count":178},"FLB","Meter, Conductivity, Induction, Remote Type",{"product_code":186,"device_name":187,"device_class":8,"k510_count":178},"MNV","Strip, Dialysate Ph Indicator",{"product_code":189,"device_name":190,"device_class":8,"k510_count":31},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",{"product_code":192,"device_name":193,"device_class":8,"k510_count":31},"FJF","Detector, Air Bubble",{"product_code":195,"device_name":196,"device_class":8,"k510_count":31},"FKJ","Filter, Blood, Dialysis",{"product_code":198,"device_name":199,"device_class":8,"k510_count":200},"FIG","Clamp, Tubing, Blood, Automatic",4,{"product_code":202,"device_name":203,"device_class":8,"k510_count":200},"FJD","Detector, Leak, Blood",{"product_code":205,"device_name":206,"device_class":8,"k510_count":200},"FKY","Connector, Tubing, Dialysate",{"product_code":208,"device_name":209,"device_class":8,"k510_count":200},"FLC","Station, Dialysis Control, Negative Pressure Type",{"product_code":211,"device_name":212,"device_class":8,"k510_count":200},"KXM","System Accessories, Extracorporeal",{"product_code":214,"device_name":215,"device_class":8,"k510_count":200},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm",{"product_code":217,"device_name":218,"device_class":8,"k510_count":219},"FID","Tubing, Dialysate",3,{"product_code":221,"device_name":222,"device_class":8,"k510_count":219},"FJB","Detector, Dialysate Level",{"product_code":224,"device_name":225,"device_class":8,"k510_count":219},"FJZ","Declotting Tray, Kit (Including Contents)",{"product_code":227,"device_name":228,"device_class":8,"k510_count":219},"FKI","Set, Dialyzer Holder",{"product_code":230,"device_name":231,"device_class":8,"k510_count":219},"FLA","Monitor, Temperature, Dialysis",{"product_code":233,"device_name":234,"device_class":8,"k510_count":235},"FKB","Connector, Blood Tubing, Infusion T",2,{"product_code":237,"device_name":238,"device_class":8,"k510_count":235},"LLB","System, Blood, Extracorporeal And Accessories",{"product_code":240,"device_name":241,"device_class":8,"k510_count":242},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass",1,{"product_code":244,"device_name":245,"device_class":8,"k510_count":242},"FIW","Alarm, Pillow Pressure",{"product_code":247,"device_name":248,"device_class":8,"k510_count":242},"FJC","Detector, Blood Level",{"product_code":250,"device_name":251,"device_class":8,"k510_count":242},"FKD","Canister, Coil",{"product_code":253,"device_name":254,"device_class":8,"k510_count":242},"FKL","Insert, Pump, Blood",{"product_code":256,"device_name":257,"device_class":8,"k510_count":242},"KQQ","Tubing, Dialysate (And Connector)",{"product_code":259,"device_name":260,"device_class":8,"k510_count":242},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration",{"product_code":262,"device_name":263,"device_class":8,"k510_count":242},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator",{"product_code":265,"device_name":266,"device_class":12,"k510_count":29},"FIA","Chair, Dialysis, Unpowered, Without Scales",{"product_code":268,"device_name":269,"device_class":8,"k510_count":29},"FIK","System, Dialysate Delivery, Recirculating",{"product_code":271,"device_name":272,"device_class":8,"k510_count":29},"FIS","Flowmeter, Dialysate",{"product_code":274,"device_name":275,"device_class":8,"k510_count":29},"FJA","Manometer, Water",{"product_code":277,"device_name":278,"device_class":8,"k510_count":29},"FJJ","Dialyzer, Twin Coil",{"product_code":280,"device_name":281,"device_class":8,"k510_count":29},"FJP","Adaptor, Y",{"product_code":283,"device_name":284,"device_class":12,"k510_count":29},"FKE","Tie, Dialysis",{"product_code":286,"device_name":287,"device_class":12,"k510_count":29},"FKF","Gun, Tie, Dialysis",{"product_code":289,"device_name":290,"device_class":8,"k510_count":29},"FKM","Adaptor, Fistula",{"product_code":292,"device_name":293,"device_class":8,"k510_count":29},"KQR","Detector, Air Or Foam",{"product_code":295,"device_name":296,"device_class":12,"k510_count":29},"MON","System, Hemodialysis, Remote Accessories",{"product_code":298,"device_name":299,"device_class":8,"k510_count":29},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":301,"device_name":302,"device_class":8,"k510_count":29},"PEV","Dialysis Administration Kit",{"product_code":304,"device_name":305,"device_class":8,"k510_count":29},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":307,"device_name":308,"device_class":8,"k510_count":29},"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)",{"product_code":310,"device_name":311,"device_class":8,"k510_count":29},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit",{"product_code":313,"device_name":314,"device_class":8,"k510_count":29},"PRO","Anti-Regurgitation Blood Tubing Kit",{"510k":316,"classification":317,"enforcement":318,"event":319,"pma":320,"warning_letter":321},"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":323,"definition_ja":30,"commentary_ja":324,"model_name":325,"source_hash":326,"reviewed_by":30,"reviewed_at":30,"created_at":327,"updated_at":327},"透析用イントラカテーテル","本品は米国FDAの規制上クラスIIに分類される医療機器であり、市販前届出（510(k)）による審査を経て市場に流通することが求められます。クラスIIは中程度のリスクを有する機器区分であり、クラスIIIに比べて簡略化された審査手続きが適用される一方、性能規格や適合性の確認を通じて安全性・有効性が担保される仕組みとなっています。","claude-sonnet-5","64a1dc0bd4642246f98fdf6b6b08401b1bbf46cd000501223637e79de131339d","2026-08-24T01:51:19.839721+00:00",{"product_code":6,"summary_ja":329,"stats":330,"stats_hash":340,"model_name":325,"created_at":341,"updated_at":341},"510(k)の累計件数は5件で、3社が参入していますが、直近5年間の届出はありません。不具合報告は累計約8件で、Malfunction（不具合）が6件、傷害が2件と報告されており、死亡例は確認されていません。回収については、これまでに実施例は確認されていません。",{"pma":331,"k510":332,"as_of":334,"events":335,"recalls":337,"top_problems":339},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":29,"latest":333,"applicants":219},"1986-09-25","2026-08",{"death":29,"other":29,"total":32,"injury":235,"last5y":29,"malfunction":178,"latest_month":336},"2015-11",{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":338},[],[],"3e0420501324bbfb11b6b284d3199a3e205113ba2430f5bab2482160bfb0ea3a","2026-08-24T04:21:40.396908+00:00",{"items":343,"total":29},[],{"items":345,"total":31},[346,351,355,357,360],{"k_number":21,"device_name":347,"applicant":348,"decision_date":333,"clearance_type":349,"decision_code":350,"statement_or_summary":30},"MODIFICATION'S TO TORAY'S B-2 SERIES","National Medical Care, Medical Products Div., Inc.","Traditional","SESE",{"k_number":22,"device_name":352,"applicant":353,"decision_date":354,"clearance_type":349,"decision_code":350,"statement_or_summary":30},"CATHETER, FEMORAL VEIN, SF 6","Sorensen Research","1977-11-29",{"k_number":19,"device_name":356,"applicant":353,"decision_date":354,"clearance_type":349,"decision_code":350,"statement_or_summary":30},"CATHETER, VEIN, FEMORAL, SF 10",{"k_number":23,"device_name":358,"applicant":353,"decision_date":359,"clearance_type":349,"decision_code":350,"statement_or_summary":30},"DNC 151 VINCA-FLO","1977-01-14",{"k_number":20,"device_name":361,"applicant":362,"decision_date":363,"clearance_type":349,"decision_code":350,"statement_or_summary":30},"TRIEX-1 HOLLOW FIBER DIALYZER","Extracorporeal Medical Specialities, Inc.","1976-12-06",{"items":365,"total":29},[]]