[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PTU":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":115,"syncDates":160},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":27,"pma_count":27,"event_count":29},2953,"PTU","Catheter, Peritoneal, Long-Term Indwelling, Exempt","2","876.5630","GU","Gastroenterology, Urology","4","This product code is the class II exempt counterpart of FJS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"fei_number":18,"registration_number":20},[19],"3030220356",[19],"","Y","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[32,41,49,57,65,73,82,90,98,106],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":38,"vector_similarity":39,"score":40},821,"腹膜透析用カテーテル","Ⅲ","34921000",0.363636,0.176471,0.607933,0.0315136,{"medical_device_id":42,"generic_name":43,"class_classification":35,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},433,"抗菌作用緊急時ブラッドアクセス留置用カテーテル","70320200",0.294872,0.155313,0.616268,0.030478,{"medical_device_id":50,"generic_name":51,"class_classification":35,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},369,"長期的使用胆管用カテーテル","10696013",0.310345,0.109325,0.604454,0.0296313,{"medical_device_id":58,"generic_name":59,"class_classification":35,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},431,"ウロキナーゼ使用緊急時ブラッドアクセス留置用カテーテル","70320400",0.25,0.136232,0.614374,0.0281772,{"medical_device_id":66,"generic_name":67,"class_classification":35,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},430,"ヘパリン使用緊急時ブラッドアクセス留置用カテーテル","70320300",0.256098,0.140351,0.60859,0.0279707,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},297,"腹膜カテーテル用吸収性カフ","Ⅳ","70589100",0.265625,0.155807,0.604626,0.0277459,{"medical_device_id":83,"generic_name":84,"class_classification":76,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},298,"コラーゲン使用腹膜カテーテル用吸収性カフ","70589200",0.240506,0.154696,0.604695,0.0270563,{"medical_device_id":91,"generic_name":92,"class_classification":35,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},381,"長期的使用腎瘻用カテーテル","10735003",0.290323,0.101639,0.59295,0.0270468,{"medical_device_id":99,"generic_name":100,"class_classification":35,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},823,"腹膜灌流用カテーテルイントロデューサキット","16992000",0.287879,0.117216,0.593179,0.027032,{"medical_device_id":107,"generic_name":108,"class_classification":109,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},2117,"経皮排液向け腹膜用カテーテル","Ⅱ","37701000",0.307692,0.114706,0.586761,0.0266106,[116,120,124,128,132,136,140,144,148,151,154,157],{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"KDJ","Set, Administration, For Peritoneal Dialysis, Disposable",113,{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"FKX","System, Peritoneal, Automatic Delivery",83,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"FJS","Catheter, Peritoneal, Long-Term Indwelling",48,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"FKO","Catheter, Peritoneal Dialysis, Single Use",16,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"PNG","Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling",15,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"KPF","System, Dialysate Delivery, Semi-Automatic, Peritoneal",13,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"MLW","Warmer, Peritoneal Dialysate",6,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"KPP","Peritoneal Dialysate Filter",3,{"product_code":149,"device_name":150,"device_class":8,"k510_count":27},"PPJ","Peritoneal Dialysis Administration Kit",{"product_code":152,"device_name":153,"device_class":8,"k510_count":27},"PPK","Peritoneal Dialysis Tubing Kit",{"product_code":155,"device_name":156,"device_class":8,"k510_count":27},"PTV","Catheter, Peritoneal Dialysis, Single Use, Exempt",{"product_code":158,"device_name":159,"device_class":8,"k510_count":27},"PTW","System, Peritoneal, Automatic Delivery, Exempt",{"510k":161,"classification":162,"enforcement":163,"event":164,"pma":165,"warning_letter":166},"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"]