[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-FOZ":3},{"classification":4,"mappedDevices":789,"similarCandidates":790,"relatedClassifications":862,"syncDates":905},{"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":782,"updated_at":783,"recall_count":784,"latest_recall_date":785,"k510_count":786,"pma_count":787,"event_count":788},5199,"FOZ","Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","2","880.5200","HO","General Hospital","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":779,"product_code":6,"review_panel":10,"gmp_exempt_flag":779,"third_party_flag":780,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":779,"medical_specialty_description":11,"summary_malfunction_reporting":781},{"k_number":17,"fei_number":524,"registration_number":723},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523],"K984059","K874582","K213085","K060174","K961552","K932946","K213664","K840862","K132153","K220626","K840815","K050114","K170283","K150611","K000632","K190001","K023253","K883415","K930048","K111366","K933467","K133280","K990236","K840355","K130518","K142136","K895734","K011860","K881976","K834227","K912358","K962938","K991406","K813374","K081953","K970736","K902527","K020785","K052564","K141026","K811171","K161779","K834255","K140270","K823017","K032843","K974543","K003187","K780105","K760163","K923323","K905009","K032777","K881215","K163358","K950301","K850398","K875082","K954112","K953252","K113565","K972264","K861015","K070020","K993515","K192493","K821929","K833092","K172204","K022756","K881236","K230616","K250292","K024007","K851327","K972254","K160374","K002786","K944968","K890435","K983916","K123267","K912563","K220584","K904150","K821371","K912165","K120839","K000087","K012128","K881767","K000665","K895768","K823351","K821577","K223018","K813345","K952861","K944410","K191232","K980566","K844113","K780350","K113429","K953811","K830541","K210037","K910564","K111939","K915824","K954428","K771381","K233106","K884701","K113700","K895191","K912158","K221827","K915065","K053120","K223648","K893546","K013800","K172496","K911251","K112542","K891087","K920828","K121488","K090502","K210929","K100775","K143610","K924968","K051355","K233529","K021139","K931027","K173354","K212370","K801414","K972263","K140504","K962226","K875177","K771573","K011982","K151513","K071538","K772011","K192676","K830573","K830539","K160592","K140419","K081690","K953805","K011937","K903545","K063469","K042862","K900263","K021130","K851101","K833091","K905415","K170336","K032292","K910799","K162894","K082997","K030479","K013287","K861479","K993691","K981368","K950737","K073471","K833135","K061250","K964048","K992198","K081113","K890751","K862153","K990390","K901640","K011967","K914528","K921955","K940634","K803238","K010410","K920128","K945521","K010034","K032274","K944660","K183399","K062108","K844219","K102520","K883866","K883980","K983409","K853988","K981905","K200266","K150407","K893965","K951620","K790968","K091709","K871546","K001795","K884325","K822776","K941417","K963867","K261041","K944504","K220756","K952645","K850460","K161681","K904558","K182252","K823565","K240359","K894371","K931073","K041345","K000235","K850369","K850887","K072419","K083454","K152272","K032962","K033500","K770751","K881666","K000997","K193278","K940385","K952058","K121073","K772354","K073520","K931729","K142797","K960764","K043446","K900116","K960051","K021557","K003553","K161866","K962577","K070451","K880260","K801537","K223788","K244059","K801941","K971339","K844193","K980493","K133856","K800786","K895812","K914378","K140136","K854308","K070705","K003245","K944368","K071382","K834073","K193158","K790914","K971991","K253235","K243599","K910572","K864949","K252398","K231239","K944511","K896774","K854566","K944336","K894611","K161777","K033853","K851981","K896813","K901263","K832558","K861117","K093546","K932947","K984055","K131555","K192533","K984590","K884577","K974015","K153298","K990308","K943023","K921270","K982558","K931668","K252513","K842133","K944302","K112290","K081420","K770511","K862480","K893003","K813396","K042504","K113622","K030571","K013073","K970669","K872998","K151698","K920028","K970644","K974764","K821679","K941678","K231626","K850349","K011297","K252677","K950118","K933050","K770510","K940441","K895597","K834393","K770181","K200373","K945053","K872585","K861725","K884806","K182538","K955053","K905463","K982805","K821372","K182870","K981382","K092629","K243403","K090122","K013182","K973561","K910566","K122544","K123734","K833079","K033250","K842577","K870403","K884259","K040427","K032417","K001616","K843033","K953120","K954887","K864038","K220772","K860256","K942045","K882242","K163513","K802918","K242281","K120337","K770403","K251654","K033843","K963196","K052881","K241115","K853701","K926405","K852078","K984614","K952757","K083429","K002142","K250682","K950284","K935090","K992732","K200891","K903347","K013556","K964049","K111236","K904648","K901701","K002033","K200263","K920638","K160235","K022099","K920635","K840116","K993518","K841880","K952256","K791918","K873050","K943349","K964966","K992532","K932789","K192230","K904121","K082362","K801575","K955839","K972262","K853348","K860290","K851142","K010406","K984189","K060341","K895942","K150109","K201075","K821699","K010021","K252137","K231401","K960013","K862130","K100974","K970864","K904122","K830765","K964050","K932071","K203069","K162377","K903732","K202060","K201717","K926097","K946170","K153280","K100282","K251155","K232234","K812137","K760319","K910565","K121007","K800525","K944367","K840183","K940775","K920133","K090973","K850276","K822023","K914180","K834480","K110443","K812159","K243105","K073241","K790967","K830972","K832624","K112347","K860474","K080793","K902135","K190855","K171530","K953335","K833657","K900056","K923702","K052389","K110794","K141138","K241845","K971990","K850278","K861510","K926544","K172506","K260539","K251422",[13,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722],"3002807725","2518902","3002806482","2024311","1282497","1713468","3008307705","3022054170","3015859709","3002558692","3011088743","3004784537","3012187635","1000117748","3006425876","1000563940","3006942602","3003915875","3003040625","3003442380","3016261803","3005609751","3005956311","3015173212","3015058854","1000160458","1000138054","3002807710","3002807111","3003674698","3010934635","3008496528","3014656749","3006082230","3017129766","3003895440","3000206435","3030626857","3010419931","3031233007","3009211636","3003775072","1721676","1000120555","3002806575","3010754844","3004785273","3014389131","3003076831","3000247873","2025816","3010621964","3012104670","1319211","3010220595","3014270673","2243072","3004111573","3013319212","3033536319","1410248","3000268902","3006097687","3010384323","3013764800","3003910417","3006846316","3015997711","3004122598","3006003617","3005747797","3011241266","3002807548","3011237770","1000512168","3004129394","3001236905","3008002452","3013557562","1220477","1043214","3012542015","1000112877","2523676","2246552","1000112968","3010041511","1000174591","3035111606","3018507299","3022728142","3012039263","3002806603","3010131137","3002468371","1000113359","1820334","3001124136","3013188547","3030574705","3030446844","3011689956","1220905","3030714660","3013298431","1000306068","1000514656","3010055973","1417592","3008397795","3004134316","3002806934","1921846","3002807350","3008403546","1710034","3014663754","3002807308","1928237","1824619","3036773433","3002806830","3003752255","3012421607","2011171","3003184529","3007207906","1721686","3042370483","2648045","3012050423","1000132332","3003382061","3003737899","1000123180","3003169040","2527072","3007836437","3004102031","3021570645","3020460367","3012494290","1625425","3009888344","3017509841","2245270","1219611","3006260740","3014579161","3002807314","3014263632","3003205539","3005987240","3002974635","3005846326","3008410596","3002806469","3013162291","3031983053","3012026312","3030733800","3015724078","3002807391","3003902955","3003560965","3016727301","3005515211","2828","3002963732","3006621386","3009291251","3002879021","3003282181","3002808464","1018233","3002601200","1035907","3010413216","1018470","3016678045","3009758019","3012809732","2024024","3022518300","3037918935","3004187702","3032916632","3009750712","3002902735","1000477110","3043226252","3016904853","3005246939","3007616112","3003058448","3010532612","3013517171","3003807466",[13,526,724,528,529,530,531,532,725,726,727,533,535,536,537,540,539,541,542,544,728,546,547,548,549,729,554,555,556,730,557,558,559,731,732,733,560,562,563,564,565,566,567,734,735,736,570,737,738,571,739,572,740,575,574,741,742,576,577,743,744,578,579,580,745,581,582,583,746,747,585,584,586,588,589,748,591,592,593,749,596,598,600,750,751,603,752,604,605,606,753,608,609,611,613,614,615,616,617,754,618,621,622,623,624,625,626,627,628,755,756,757,758,759,629,760,632,633,635,637,638,639,640,641,643,761,762,644,645,763,764,648,765,649,650,651,652,653,654,655,766,767,768,661,662,663,664,665,666,667,668,669,670,671,769,672,673,674,675,770,771,677,680,772,773,682,774,683,684,685,686,688,775,690,776,691,694,695,777,699,700,701,702,703,704,705,706,707,708,709,710,711,712,778,715,716,717,718,720,721],"1644312","1319639","2320762","1054241","1223004","9610847","9616088","9612030","9681835","3005941719","8043983","8021545","9610987","9616157","1422634","1055236","1064858","2032098","9616567","9615588","1055927","1647137","1423507","9612126","9610825","9617594","8041187","8041145","9610048","9680143","1123137","9680794","8020889","2030624","2032112","9612086","3002807090","3011137372","1061124","8010026","9617604","2029015","9612433","9611446","3003916417","9610849","9617592","1423537","9680091","8020785","1056186","3010882065","9616991","9615908","3004519921","N","Y","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-19T02:39:39.426476+00:00",394,"2026-05-13",506,0,48767,[],[791,799,807,814,821,828,834,842,849,855],{"medical_device_id":792,"generic_name":793,"class_classification":794,"jmdn_code":795,"name_similarity":796,"definition_similarity":787,"vector_similarity":797,"score":798},2116,"短期的使用胸腔カテーテル","Ⅱ","36247002",0.308824,0.741818,0.0317781,{"medical_device_id":800,"generic_name":801,"class_classification":802,"jmdn_code":803,"name_similarity":804,"definition_similarity":787,"vector_similarity":805,"score":806},407,"末梢血管用血管内カテーテル","Ⅲ","34920000",0.347222,0.721325,0.0313188,{"medical_device_id":808,"generic_name":809,"class_classification":794,"jmdn_code":810,"name_similarity":811,"definition_similarity":787,"vector_similarity":812,"score":813},2023,"非中心循環系血管内カテーテル","40601000",0.298701,0.724069,0.0307765,{"medical_device_id":815,"generic_name":816,"class_classification":794,"jmdn_code":817,"name_similarity":818,"definition_similarity":787,"vector_similarity":819,"score":820},1922,"短期的使用胆管用カテーテル","10696022",0.267606,0.723653,0.0294691,{"medical_device_id":822,"generic_name":823,"class_classification":794,"jmdn_code":824,"name_similarity":825,"definition_similarity":787,"vector_similarity":826,"score":827},1997,"短期的使用腎瘻用カテーテル","10735002",0.253333,0.738204,0.0287873,{"medical_device_id":829,"generic_name":830,"class_classification":794,"jmdn_code":831,"name_similarity":818,"definition_similarity":787,"vector_similarity":832,"score":833},2066,"短期的使用アンブレラカテーテル","10760002",0.714644,0.0281746,{"medical_device_id":835,"generic_name":836,"class_classification":837,"jmdn_code":838,"name_similarity":839,"definition_similarity":787,"vector_similarity":840,"score":841},95,"中心循環系血管処置用チューブ及びカテーテル","Ⅳ","70288000",0.296296,0.691853,0.0277459,{"medical_device_id":843,"generic_name":844,"class_classification":794,"jmdn_code":845,"name_similarity":846,"definition_similarity":787,"vector_similarity":847,"score":848},2020,"ガイディング用血管内カテーテル","17846102",0.323944,0.683545,0.0276377,{"medical_device_id":850,"generic_name":851,"class_classification":794,"jmdn_code":852,"name_similarity":825,"definition_similarity":787,"vector_similarity":853,"score":854},1896,"短期的使用空腸瘻用カテーテル","10731002",0.70412,0.0267094,{"medical_device_id":856,"generic_name":857,"class_classification":794,"jmdn_code":858,"name_similarity":859,"definition_similarity":787,"vector_similarity":860,"score":861},1999,"短期的使用瘻排液向け泌尿器用カテーテル","31074000",0.232558,0.720264,0.0266106,[863,867,871,875,879,883,887,890,893,896,899,902],{"product_code":864,"device_name":865,"device_class":8,"k510_count":866},"NGT","Saline, Vascular Access Flush",40,{"product_code":868,"device_name":869,"device_class":8,"k510_count":870},"FOS","Catheter, Umbilical Artery",34,{"product_code":872,"device_name":873,"device_class":8,"k510_count":874},"LRS","I.V. Start Kit",30,{"product_code":876,"device_name":877,"device_class":8,"k510_count":878},"PND","Midline Catheter",13,{"product_code":880,"device_name":881,"device_class":8,"k510_count":882},"NZW","Heparin, Vascular Access Flush",7,{"product_code":884,"device_name":885,"device_class":8,"k510_count":886},"QTI","Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device",1,{"product_code":888,"device_name":889,"device_class":8,"k510_count":886},"SEF","Central Venous Catheter With Manual Insertion System",{"product_code":891,"device_name":892,"device_class":8,"k510_count":787},"NZX","Water, Vascular Access Flush",{"product_code":894,"device_name":895,"device_class":8,"k510_count":787},"OWL","Peripheral Catheter Insertion Kit",{"product_code":897,"device_name":898,"device_class":8,"k510_count":787},"PEF","Heparin Flush In 0.45% Sodium Chloride",{"product_code":900,"device_name":901,"device_class":8,"k510_count":787},"PEZ","Central Venous Catheter Dressing Change Kit",{"product_code":903,"device_name":904,"device_class":8,"k510_count":787},"PXJ","Umbilical Catheter Insertion Tray",{"510k":906,"classification":907,"enforcement":908,"event":909,"pma":910,"warning_letter":911},"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","2026-08-19T04:07:02.603+00:00"]