[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OEX":3},{"classification":4,"mappedDevices":51,"similarCandidates":52,"relatedClassifications":135,"syncDates":156},{"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":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":49,"event_count":50},5598,"OEX","Cardiovascular Catheter Sheath Introducer Kit","2","870.1340","CV","Cardiovascular","7","This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov\u002Fcdrh\u002Fode\u002Fconvkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":42,"device_class":8,"implant_flag":43,"product_code":6,"review_panel":10,"gmp_exempt_flag":43,"third_party_flag":43,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":42,"life_sustain_support_flag":43,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"fei_number":17,"registration_number":36},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35],"3033589330","3015309643","3015225571","3004111573","3002902735","1643817","1000512168","3020368143","3001236905","3011642792","3006950086","3007329020","3009888344","1000123180","1721504","3012536737","1721676","3003094851",[18,37,19,20,21,38,23,25,39,29,27,28,30,32,33,34,40,41],"1724474","1423537","9616088","1123137","1061124","","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",2,null,0,17,[],[53,62,70,79,86,95,103,111,119,127],{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},2026,"カテーテルイントロデューサ","Ⅱ","10678102",0.452381,0.126214,0.701706,0.031754,{"medical_device_id":63,"generic_name":64,"class_classification":56,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":69},2087,"止血弁付カテーテルイントロデューサ","36079000",0.298507,0.132258,0.70628,0.0294624,{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},394,"ヘパリン使用カテーテルイントロデューサ","Ⅲ","10678203",0.339286,0.110738,0.694989,0.0294181,{"medical_device_id":80,"generic_name":81,"class_classification":73,"jmdn_code":82,"name_similarity":58,"definition_similarity":83,"vector_similarity":84,"score":85},395,"イントロデューサカテーテル","70281000",0.183333,0.66739,0.0293805,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},94,"心血管用カテーテルガイドワイヤ","Ⅳ","70287009",0.423077,0.155367,0.654502,0.0280681,{"medical_device_id":96,"generic_name":97,"class_classification":56,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},2029,"静脈用カテーテルイントロデューサキット","12161102",0.275862,0.0874525,0.703433,0.0275009,{"medical_device_id":104,"generic_name":105,"class_classification":89,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},75,"心臓用カテーテルイントロデューサキット","10598000",0.283019,0.116923,0.691842,0.0266879,{"medical_device_id":112,"generic_name":113,"class_classification":56,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},2097,"消化器用カテーテルイントロデューサ","70329000",0.333333,0.125424,0.645923,0.0254481,{"medical_device_id":120,"generic_name":121,"class_classification":73,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},400,"血管用カテーテルガイドワイヤ","35094103",0.296296,0.160606,0.649631,0.0253265,{"medical_device_id":128,"generic_name":129,"class_classification":56,"jmdn_code":130,"name_similarity":131,"definition_similarity":132,"vector_similarity":133,"score":134},2079,"脳外科用イントロデューサ","70322000",0.244898,0.207101,0.669188,0.0244444,[136,140,144,148,150,153],{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"DYB","Introducer, Catheter",706,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"PNE","Reprocessed Catheter Introducer",7,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"OFC","Catheter Introducer Kit",1,{"product_code":149,"device_name":146,"device_class":8,"k510_count":49},"OFD",{"product_code":151,"device_name":152,"device_class":8,"k510_count":49},"OFJ","Lead Introducer Kit",{"product_code":154,"device_name":155,"device_class":8,"k510_count":49},"OFL","Percutaneous Sheath Introducer Kit",{"510k":157,"classification":158,"enforcement":159,"event":160,"pma":161,"warning_letter":162},"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"]