[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SEU":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":118,"syncDates":119,"translation":126,"marketSummary":133,"recalls":146,"k510s":148,"pmas":155},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":33},3467,"SEU","Peripheral Temporary And Retrievable Stent System","2","870.5110","CV","Cardiovascular","1","A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":28,"device_class":8,"implant_flag":29,"product_code":6,"review_panel":10,"gmp_exempt_flag":29,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":28,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":19,"registration_number":25},[18],"DEN240048",[20,21,22,23,24],"3008789872","3027058844","3001600991","3000206435","3009526986",[20,26,21,27,24],"2531463","2030624","","N","Ineligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:49.029844+00:00",0,null,1,[],[38,47,56,64,72,79,87,95,103,111],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},1171,"中心循環系ステントグラフト","Ⅳ","47932114",0.194444,0.23219,0.722748,0.029236,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},556,"尿管用ステント","Ⅲ","35645000",0.192308,0.27003,0.714905,0.0291986,{"medical_device_id":57,"generic_name":58,"class_classification":41,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},1077,"振動式末梢血管貫通用カテーテルシステム","46850004",0.240506,0.194805,0.694324,0.0282187,{"medical_device_id":65,"generic_name":66,"class_classification":50,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},331,"中枢神経向け一時使用超音波診断用プローブ","70021000",0.282609,0.20362,0.639702,0.0163934,{"medical_device_id":73,"generic_name":74,"class_classification":50,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":71},559,"血管用ステント","36035003",0.107143,0.263006,0.754277,{"medical_device_id":80,"generic_name":81,"class_classification":41,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},226,"冠動脈ステント","36035004",0.148148,0.269461,0.736352,0.016129,{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":86},3649,"一時的使用胃食道用滅菌済みチューブ及びカテーテル","Ⅰ","70231000",0.243902,0.210317,0.644384,{"medical_device_id":96,"generic_name":97,"class_classification":41,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},1160,"大静脈用ステント","71070004",0.105263,0.262687,0.730715,0.015873,{"medical_device_id":104,"generic_name":105,"class_classification":41,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},225,"心血管用ステント","34179000",0.0967742,0.253602,0.730377,0.015625,{"medical_device_id":112,"generic_name":113,"class_classification":90,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":110},3878,"手術台システム","37325000",0.22807,0.22963,0.570253,[],{"510k":120,"classification":121,"enforcement":122,"event":123,"pma":124,"warning_letter":125},"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":127,"definition_ja":128,"commentary_ja":129,"model_name":130,"source_hash":131,"reviewed_by":34,"reviewed_at":34,"created_at":132,"updated_at":132},"末梢用一時留置・回収式ステントシステム","末梢用一時留置・回収式ステントシステムとは、狭窄病変を治療するためにデリバリーカテーテルシステムを介して末梢血管系に留置される一時的な足場であり、治療の成功後に回収・除去されるよう設計された機器である。","本品は米国の医療機器規制ではクラスIIに分類されており、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可能です。510(k)は、既存の類似機器（プレディケートデバイス）との実質的同等性を示すことで承認を得る仕組みであり、クラスIIIで求められる市販前承認（PMA）よりも簡略化された審査経路です。","claude-sonnet-5","888736040009aa9093bf14aa03b08d4637c07d5ebe86237b7750baeab4987f6c","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":134,"stats":135,"stats_hash":144,"model_name":130,"created_at":145,"updated_at":145},"本製品コードは510(k)累計1件、参入企業数1社で、直近5年でも1件の届出が確認されており、2025年5月に最新の判定が行われています。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、確認されていません。",{"pma":136,"k510":137,"as_of":139,"events":140,"recalls":141,"top_problems":143},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":35,"latest":138,"applicants":35},"2025-05-29","2026-08",{"death":33,"other":33,"total":33,"injury":33,"last5y":33,"malfunction":33,"latest_month":34},{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":142},[],[],"51a39a97b688d6e8c610251663f161bd374649cd1d0100f4785087ed693ec3a1","2026-08-24T05:23:16.025025+00:00",{"items":147,"total":33},[],{"items":149,"total":35},[150],{"k_number":18,"device_name":151,"applicant":152,"decision_date":138,"clearance_type":153,"decision_code":154,"statement_or_summary":34},"Spur Peripheral Retrievable Stent System","Reflow Medical, Inc.","Direct","DENG",{"items":156,"total":33},[]]