[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NQH":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":116,"syncDates":117,"translation":124,"marketSummary":131,"recalls":149,"k510s":151,"pmas":175},{"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":15,"raw":16,"created_at":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":32,"pma_count":30,"event_count":33},2559,"NQH","Sensor, Pressure, Aneurysm, Implantable","2","870.2855","CV","Cardiovascular","1","This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":24,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":10,"gmp_exempt_flag":26,"third_party_flag":26,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":24,"life_sustain_support_flag":26,"medical_specialty_description":11,"summary_malfunction_reporting":27},{"k_number":18},[19,20,21,22,23],"K061046","K082191","K070680","K070448","DEN050006","","Y","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:49.285889+00:00",0,null,5,33,[],[36,45,54,62,70,77,85,93,101,108],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},167,"体内用動脈瘤クリップ","Ⅳ","34958000",0.5,0.220859,0.710665,0.0281581,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},1433,"圧力用増幅器","Ⅱ","36748000",0.244444,0.234483,0.73256,0.0270516,{"medical_device_id":55,"generic_name":56,"class_classification":48,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},1410,"再使用可能な圧トランスデューサ用ドーム","37312000",0.20339,0.2,0.772263,0.0163934,{"medical_device_id":63,"generic_name":64,"class_classification":39,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},237,"吸収性体内埋植用シート","70499000",0.3125,0.175676,0.597401,0.016129,{"medical_device_id":71,"generic_name":72,"class_classification":48,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":69},1411,"単回使用圧トランスデューサ用ドーム","37257000",0.177419,0.222222,0.757368,{"medical_device_id":78,"generic_name":79,"class_classification":39,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},206,"植込み型ペースメーカアダプタ","36102000",0.288462,0.17757,0.621003,0.015873,{"medical_device_id":86,"generic_name":87,"class_classification":88,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":84},3326,"アネロイド式血圧計","Ⅰ","16156000",0.0689655,0.217391,0.745372,{"medical_device_id":94,"generic_name":95,"class_classification":39,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},69,"脊椎接触圧力モニタリング用キット","70272000",0.169231,0.25,0.743748,0.015625,{"medical_device_id":102,"generic_name":103,"class_classification":39,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":100},156,"体内用サージカルテープ","34046000",0.285714,0.145251,0.591875,{"medical_device_id":109,"generic_name":110,"class_classification":39,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},1141,"植込み医療機器用吸収性スペーサ","71062004",0.271186,0.193548,0.632097,0.0153846,[],{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"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":125,"definition_ja":126,"commentary_ja":127,"model_name":128,"source_hash":129,"reviewed_by":31,"reviewed_at":31,"created_at":130,"updated_at":130},"植込み型動脈瘤圧センサ","本装置は、血管内治療の施術中及び施術後において、動脈瘤嚢内の圧力を測定することを目的とする。","この機器は米国の規制ではクラスIIに分類されており、市販前届出（510(k)）の対象となっています。510(k)は、既存の合法販売されている類似機器（既承認品）との実質的同等性を示すことで市販が認められる審査区分であり、クラスIII機器に適用される市販前承認（PMA）よりも簡略化された手続きです。","claude-sonnet-5","ee273de4db673b0b3e21209348b61f5e7ace351f779efa010475cc74c31401ec","2026-08-24T02:18:13.311568+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":147,"model_name":128,"created_at":148,"updated_at":148},"本製品コードにおける510(k)の累計届出件数は約5件で、参入企業数は1社、直近5年間の新規届出は確認されていません。不具合報告（MDR）の累計件数は約30件で、内訳は死亡1件、傷害が約10件、不具合（Malfunction）が約20件、その他が約5件となっており、直近5年間の報告は確認されていません。回収については累計0件で、クラスIを含む回収の実績は確認されていません。",{"pma":134,"k510":135,"as_of":138,"events":139,"recalls":144,"top_problems":146},{"latest":31,"originals":30,"supplements":30},{"total":32,"last5y":30,"latest":136,"applicants":137},"2008-08-19",1,"2026-08",{"death":137,"other":140,"total":33,"injury":141,"last5y":30,"malfunction":142,"latest_month":143},4,9,19,"2009-06",{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":145},[],[],"8110163e3350c3e0fffb18b1569e476d4f1c89172d28779d690e6e07988379b7","2026-08-24T04:59:09.208125+00:00",{"items":150,"total":30},[],{"items":152,"total":32},[153,159,163,166,170],{"k_number":20,"device_name":154,"applicant":155,"decision_date":136,"clearance_type":156,"decision_code":157,"statement_or_summary":158},"CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080","Cardiomems, Inc.","Abbreviated","SESE","Summary",{"k_number":21,"device_name":160,"applicant":155,"decision_date":161,"clearance_type":162,"decision_code":157,"statement_or_summary":158},"CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080","2007-04-05","Special",{"k_number":22,"device_name":164,"applicant":155,"decision_date":165,"clearance_type":156,"decision_code":157,"statement_or_summary":158},"CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001","2007-03-15",{"k_number":19,"device_name":167,"applicant":155,"decision_date":168,"clearance_type":169,"decision_code":157,"statement_or_summary":158},"CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001","2006-10-12","Traditional",{"k_number":23,"device_name":171,"applicant":155,"decision_date":172,"clearance_type":173,"decision_code":174,"statement_or_summary":31},"CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM","2005-10-28","Post-NSE","DENG",{"items":176,"total":30},[]]