[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NKR":3},{"classification":4,"mappedDevices":24,"similarCandidates":25,"relatedClassifications":106,"syncDates":115},{"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":14,"raw":15,"created_at":21,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":22,"event_count":22},5268,"NKR","System, Catheter Control, Reprocessed","2","870.1290","CV","Cardiovascular","1","Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https:\u002F\u002Fwww.govinfo.gov\u002Fcontent\u002Fpkg\u002FFR-2005-09-29\u002Fpdf\u002F05-19510.pdf).",false,{"openfda":16,"definition":13,"device_name":7,"review_code":17,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":10,"gmp_exempt_flag":18,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":17,"life_sustain_support_flag":18,"medical_specialty_description":11,"summary_malfunction_reporting":20},{},"","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00",0,null,[],[26,35,44,52,59,68,76,84,92,99],{"medical_device_id":27,"generic_name":28,"class_classification":29,"jmdn_code":30,"name_similarity":31,"definition_similarity":32,"vector_similarity":33,"score":34},1161,"再製造心臓用カテーテル型電極","Ⅳ","46359004",0.407407,0.158046,0.651714,0.0327869,{"medical_device_id":36,"generic_name":37,"class_classification":38,"jmdn_code":39,"name_similarity":40,"definition_similarity":41,"vector_similarity":42,"score":43},3691,"カテーテルコントローラ操作ユニット","Ⅰ","31742000",0.333333,0.160338,0.615444,0.0305504,{"medical_device_id":45,"generic_name":46,"class_classification":38,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},3656,"耳鼻咽喉科用カテーテル","16432001",0.23913,0.165217,0.620114,0.0277303,{"medical_device_id":53,"generic_name":54,"class_classification":38,"jmdn_code":55,"name_similarity":48,"definition_similarity":56,"vector_similarity":57,"score":58},3839,"再使用可能な耳科用カテーテル","33395000",0.147727,0.626186,0.0276732,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},692,"透析用監視装置","Ⅲ","36424000",0.272727,0.129707,0.602888,0.027619,{"medical_device_id":69,"generic_name":70,"class_classification":62,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},1135,"心臓・中心循環系用カテーテル操作装置","71056003",0.231884,0.139442,0.604321,0.0253265,{"medical_device_id":77,"generic_name":78,"class_classification":62,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},986,"腎臓ウォータージェットカテーテルシステム","32070000",0.382979,0.0979592,0.571716,0.016129,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":83},2186,"再使用可能な能動型機器接続用逆流防止バルブ","Ⅱ","42548002",0.0740741,0.149321,0.634842,{"medical_device_id":93,"generic_name":94,"class_classification":87,"jmdn_code":95,"name_similarity":40,"definition_similarity":96,"vector_similarity":97,"score":98},2556,"トレパンシステムコントロールユニット","43928000",0.175373,0.5292,0.015873,{"medical_device_id":100,"generic_name":101,"class_classification":38,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":98},3733,"再使用可能なインライン逆流防止バルブ","42548001",0.0428571,0.153465,0.628691,[107,111],{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"DXX","System, Catheter Control, Steerable",33,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"NDQ","System, Catheter Or Guidewire, Steerable (Magnetic)",2,{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]