[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NLG":3},{"classification":4,"mappedDevices":39,"similarCandidates":40,"relatedClassifications":123,"syncDates":136},{"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":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":38},4409,"NLG","Catheter, Intracardiac Mapping, High-Density, Reprocessed","2","870.1220","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":30,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":30,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":17,"fei_number":21,"registration_number":28},[18,19,20],"K211662","K190785","K212776",[22,23,24,25,26,27],"3011276773","2183744","3003076831","3009888344","3011024991","3011610434",[22,23,29,25,26,27],"2032112","","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,7,[],[41,50,59,68,76,84,92,100,107,115],{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},1161,"再製造心臓用カテーテル型電極","Ⅳ","46359004",0.391304,0.158046,0.675828,0.0327869,{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},334,"心臓カテーテル用検査装置","Ⅲ","70052003",0.230769,0.123853,0.637714,0.028169,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},1515,"心臓内オキシメータモジュール","Ⅱ","37172000",0.253731,0.148387,0.619879,0.0276732,{"medical_device_id":69,"generic_name":70,"class_classification":44,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},2,"心臓カテーテル付検査装置","70052004",0.214286,0.126829,0.65031,0.0274328,{"medical_device_id":77,"generic_name":78,"class_classification":62,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},2994,"心臓マッピングシステムワークステーション","31742002",0.205128,0.152824,0.664239,0.027109,{"medical_device_id":85,"generic_name":86,"class_classification":53,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},1135,"心臓・中心循環系用カテーテル操作装置","71056003",0.22093,0.139442,0.619132,0.0256034,{"medical_device_id":93,"generic_name":94,"class_classification":44,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},57,"ペーシング向け循環器用カテーテル","35854110",0.283333,0.0958904,0.597382,0.016129,{"medical_device_id":101,"generic_name":102,"class_classification":44,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":99},1186,"再製造中心循環系血管内超音波カテーテル","64174004",0.17,0.133562,0.665156,{"medical_device_id":108,"generic_name":109,"class_classification":62,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1520,"心臓内オキシメータ","15200000",0.262295,0.137546,0.59416,0.015873,{"medical_device_id":116,"generic_name":117,"class_classification":62,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},3006,"弁形成術用弁機能評価用バルーン型カテーテル","71038002",0.122449,0.149254,0.654436,0.015625,[124,128,132],{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"DRF","Catheter, Electrode Recording, Or Probe, Electrode Recording",185,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"NLH","Catheter, Recording, Electrode, Reprocessed",70,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"MTD","Catheter, Intracardiac Mapping, High-Density Array",34,{"510k":137,"classification":138,"enforcement":139,"event":140,"pma":141,"warning_letter":142},"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","2026-08-19T04:07:02.603+00:00"]