[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OMZ":3},{"classification":4,"mappedDevices":51,"similarCandidates":52,"relatedClassifications":135,"syncDates":181},{"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":47,"event_count":50},1594,"OMZ","Pulmonary (Pulmonic) Valvuloplasty Catheters\u002FPercutaneous Valvuloplasty Catheter","2","870.1250","CV","Cardiovascular","1","Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve.  Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.",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},{"k_number":17,"fei_number":23,"registration_number":37},[18,19,20,21,22],"K014124","K122367","K102473","K131002","K153069",[24,25,26,27,28,29,30,31,32,33,34,35,36],"2528981","2015691","3006082230","3003245778","1318694","3011088743","2020394","1713910","1018233","2011171","1721676","3002468371","1000160215",[24,25,38,39,26,28,29,30,40,41,32,33,34],"9618000","9617592","1646831","3008500478","","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,21,[],[53,62,71,79,87,95,103,111,119,127],{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},84,"バルーン拡張式弁形成術用カテーテル","Ⅳ","17453000",0.338235,0.224215,0.794575,0.0322665,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},3006,"弁形成術用弁機能評価用バルーン型カテーテル","Ⅱ","71038002",0.280488,0.24735,0.770774,0.0310544,{"medical_device_id":72,"generic_name":73,"class_classification":56,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},71,"肺動脈用カテーテル","35889000",0.345455,0.249084,0.720352,0.0308349,{"medical_device_id":80,"generic_name":81,"class_classification":56,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},1127,"肺動脈カテーテル交換用カテーテル","17846134",0.273973,0.272031,0.748112,0.0305789,{"medical_device_id":88,"generic_name":89,"class_classification":65,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},2117,"経皮排液向け腹膜用カテーテル","37701000",0.328358,0.205674,0.705933,0.0291385,{"medical_device_id":96,"generic_name":97,"class_classification":56,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},86,"バルーン拡張式冠動脈灌流型血管形成術用カテーテル","17521000",0.26506,0.198113,0.713127,0.028169,{"medical_device_id":104,"generic_name":105,"class_classification":65,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110},2006,"経皮泌尿器用カテーテル","70264000",0.360656,0.24424,0.690091,0.0277571,{"medical_device_id":112,"generic_name":113,"class_classification":56,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118},85,"アテローム切除型血管形成術用カテーテル","17519000",0.230769,0.292517,0.719046,0.0276506,{"medical_device_id":120,"generic_name":121,"class_classification":56,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},44,"冠動脈灌流用カテーテル","34914100",0.262295,0.109649,0.711694,0.0272222,{"medical_device_id":128,"generic_name":129,"class_classification":56,"jmdn_code":130,"name_similarity":131,"definition_similarity":132,"vector_similarity":133,"score":134},1105,"経カテーテルブタ心のう膜弁","60245114",0.186667,0.296429,0.7362,0.0271493,[136,140,144,148,152,156,160,164,168,172,175,178],{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"DQY","Catheter, Percutaneous",893,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"LIT","Catheter, Angioplasty, Peripheral, Transluminal",403,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"NRY","Catheter, Thrombus Retriever",110,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"QJP","Catheter, Percutaneous, Neurovasculature",96,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"PDU","Catheter For Crossing Total Occlusions",57,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"PNO","Catheter, Percutaneous, Cutting\u002FScoring",45,{"product_code":161,"device_name":162,"device_class":8,"k510_count":163},"NTE","Temporary Carotid Catheter For Embolic Capture",36,{"product_code":165,"device_name":166,"device_class":8,"k510_count":167},"NFA","Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection",22,{"product_code":169,"device_name":170,"device_class":8,"k510_count":171},"PPN","Percutaneous Catheter, Ultrasound",13,{"product_code":173,"device_name":174,"device_class":8,"k510_count":49},"NVM","Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon",{"product_code":176,"device_name":177,"device_class":8,"k510_count":47},"NMM","Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed",{"product_code":179,"device_name":180,"device_class":8,"k510_count":47},"OFK","Percutaneous Atrial Catheter Kit",{"510k":182,"classification":183,"enforcement":184,"event":185,"pma":186,"warning_letter":187},"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"]