[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NYU":3},{"classification":4,"mappedDevices":44,"similarCandidates":45,"relatedClassifications":127,"syncDates":234},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":42,"event_count":43},1369,"NYU","Catheter, Hemodialysis, Implanted, Coated","2","876.5540","GU","Gastroenterology, Urology","1","Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":33,"device_class":8,"implant_flag":34,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":33,"life_sustain_support_flag":34,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":18,"fei_number":21,"registration_number":30},[19,20],"K112477","K060509",[22,23,24,25,26,27,28,29],"3030574705","1282497","3017210488","3002807391","1000138054","3015453963","3009211636","3014461810",[22,23,24,27,28,31,29,32],"1319639","9610849","","Y","N","Ineligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",30,"2015-12-02",2,0,98,[],[46,55,64,72,80,88,96,104,112,119],{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":52,"vector_similarity":53,"score":54},428,"植込み型血液透析用カテーテル","Ⅲ","37278000",0.613636,0.219355,0.793804,0.0327869,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},143,"ヘパリン使用体内植込み用カテーテル","Ⅳ","70385000",0.510638,0.235294,0.765136,0.032002,{"medical_device_id":65,"generic_name":66,"class_classification":49,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},765,"ヘパリン使用透析用血液回路セット","34999203",0.363636,0.256198,0.766477,0.0315136,{"medical_device_id":73,"generic_name":74,"class_classification":49,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},429,"閉鎖式血液透析用カテーテル","42452000",0.428571,0.215278,0.73475,0.0295716,{"medical_device_id":81,"generic_name":82,"class_classification":49,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},691,"人工腎臓装置","34995000",0.302326,0.203252,0.753377,0.0294691,{"medical_device_id":89,"generic_name":90,"class_classification":58,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},39,"ヘパリン使用血管向け灌流用カテーテル","10739200",0.278689,0.152,0.740973,0.0263339,{"medical_device_id":97,"generic_name":98,"class_classification":49,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},462,"ヘパリン使用皮下用ポート及びカテーテル","33923200",0.283333,0.12709,0.73056,0.0257086,{"medical_device_id":105,"generic_name":106,"class_classification":58,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},76,"中心循環系塞栓除去用カテーテル","10714004",0.128571,0.23431,0.754748,0.015625,{"medical_device_id":113,"generic_name":114,"class_classification":58,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":111},142,"体内植込み用カテーテル","70384000",0.390244,0.234694,0.697543,{"medical_device_id":120,"generic_name":121,"class_classification":49,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},406,"マイクロダイアリシスカテーテル","70297000",0.369565,0.149038,0.672716,0.0151515,[128,132,136,140,144,148,152,156,160,164,168,172,175,179,182,185,188,192,195,198,201,204,207,210,213,216,219,222,225,228,231],{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"MSD","Catheter, Hemodialysis, Implanted",124,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"FIE","Needle, Fistula",80,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"LFJ","Catheter, Subclavian",65,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"MPB","Catheter, Hemodialysis, Non-Implanted",38,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"FIQ","Cannula, A-V Shunt",23,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"LFK","Catheter, Femoral",16,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"NIE","Catheter, Hemodialysis, Triple Lumen, Non-Implanted",12,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"NFK","Kit, Repair, Catheter, Hemodialysis",11,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"KNZ","Accessories, A-V Shunt",10,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"LBW","Set, Dialysis, Single Needle (Co-Axial Flow)",5,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"FKN","Adaptor, Shunt",4,{"product_code":173,"device_name":174,"device_class":8,"k510_count":171},"NQJ","Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use",{"product_code":176,"device_name":177,"device_class":12,"k510_count":178},"FJQ","Connector, Shunt",3,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"FKA","Dilator, Vessel",{"product_code":183,"device_name":184,"device_class":8,"k510_count":178},"FKW","Tip, Vessel",{"product_code":186,"device_name":187,"device_class":8,"k510_count":41},"PEH","Hemodialysis Catheter Luer End Cap",{"product_code":189,"device_name":190,"device_class":12,"k510_count":191},"FKC","Clamp, Cannula",1,{"product_code":193,"device_name":194,"device_class":8,"k510_count":191},"KNR","Adapter, A-V Shunt Or Fistula",{"product_code":196,"device_name":197,"device_class":8,"k510_count":191},"PFH","Venous Window Needle Guide",{"product_code":199,"device_name":200,"device_class":8,"k510_count":42},"FJM","Guard, Shunt",{"product_code":202,"device_name":203,"device_class":8,"k510_count":42},"FJN","Stabilizer, Shunt",{"product_code":205,"device_name":206,"device_class":12,"k510_count":42},"FJO","Plier, Tube",{"product_code":208,"device_name":209,"device_class":12,"k510_count":42},"FJR","Forceps, Disconnect",{"product_code":211,"device_name":212,"device_class":12,"k510_count":42},"FJW","Ring, Joint",{"product_code":214,"device_name":215,"device_class":12,"k510_count":42},"FJX","Ring, Crimp",{"product_code":217,"device_name":218,"device_class":12,"k510_count":42},"FJY","Plier, Crimp",{"product_code":220,"device_name":221,"device_class":8,"k510_count":42},"NIF","Catheter, Hemodialysis, Triple Lumen, Implanted",{"product_code":223,"device_name":224,"device_class":8,"k510_count":42},"NNE","Needle, Fistula, Reprocessed",{"product_code":226,"device_name":227,"device_class":12,"k510_count":42},"NOO","Clamp, Dialysis Arm",{"product_code":229,"device_name":230,"device_class":8,"k510_count":42},"PKI","Fully Subcutaneous Implanted Hemodialysis Catheter",{"product_code":232,"device_name":233,"device_class":8,"k510_count":42},"PPO","Multi-Lumen Hemodialysis Catheterization Kit",{"510k":235,"classification":236,"enforcement":237,"event":238,"pma":239,"warning_letter":240},"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"]