{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "third_party_flag": "N", "city": "Maple Grove", "advisory_committee_description": "Cardiovascular", "address_1": "Three Scimed Pl.", "address_2": "", "statement_or_summary": "Summary", "product_code": "DQX", "openfda": { "registration_number": [ "3014656749", "3007113487", "3020968442", "3015489752", "3007146453", "2133928", "2939561", "3009211636", "2939520", "3003775027", "3008627763", "3004784537", "2029214", "2183744", "3024682301", "3030447506", "3007635982", "3016678045", "1223004", "3011706110", "3000247873", "3010131137", "3011137372", "3013764800", "1293141", "2219920", "3016761372", "1055236", "3007830707", "3009490946", "3007064586", "3007738736", "3007361214", "3035642068", "1220452", "3006082230", "3008403546", "3010532612", "3014716786", "1061124", "3010432890", "3008439199", "2184149", "1824619", "3008264254", "3018784828", "2183870", "2024024", "1018470", "1123137", "3003289691", "1422634", "2518902", "3009121749", "3013750125", "1016427", "3024743081", "2017865", "3007138831", "3009600098", "9610849", "3014461810", "9681834", "3030446844", "3013656790", "9612812", "2134285", "3011050570", "3008002401", "3010665433", "3004365956", "1028232", "2024168", "3009756153", "3010273872", "3009380063", "3013557562", "3008307705", "3015173212", "3006425876", "2030624", "3007695959", "3020778", "2024311", "3011564431", "9616088", "3010291427", "9614758", "1423537", "3013023134", "3014499739", "3001124136", "3005012805", "3004111573", "3013611763", "9616662", "1721504", "2528981", "2953200", "3009546466", "9680794", "3030733800", "1221806", "1043214", "3008837339", "1225687", "3015124694", "3002807314", "2134244", "3012050423", "3012931345", "2011171", "3000126629", "3042175841", "3003790304", "3005941719", "2135147", "3009957947", "3004091615", "3005580113", "3012154226", "3009526575", "3012497308", "2126666", "3012159165", "3033589330", "3007284006", "3035372913", "3010163695", "3002917664", "3012536737", "3030452144", "1417485", "9617592", "3000268902", "3008114965", "9611446", "3010041511", "3015531723", "2020394", "1644312", "1282497", "3006950086", "1721676", "3004519921", "3003915875", "3003084417", "3006891611", "3004605321", "3014222368", "3014246639", "3004748528", "2025587", "1047429", "3017961114", "1000121056", "3009564766", "1030451", "9616684", "3015453963", "3007628272", "3017210488", "3008363989", "1625425", "2248146", "3003768277", "3008988055", "3039642752", "3010155661", "1721686", "2124215", "9614279", "9681477", "3003780911", "1018233", "8023054", "3012223769", "1649395", "1226348", "1000393132", "2521402", "3015309643", "3009039068", "3008061490", "1724474", "3010419931", "8010026", "3002808486", "3026317086", "3015550451", "1928237", "3014579161", "3027260597", "3015225571", "3010882065", "2245270", "1720929", "3013943846", "3019751610", "1220477", "3006946276", "3013288201", "3013162291", "3036802499", "1820334", "1319211", "1064858", "3013666336", "1313046", "1118880", "3015910259", "3020954746", "3014977413", "2134812", "3012179728", "3016119728", "3014279513", "9611665", "2029275", "1056553", "1319639", "2134265", "2527072", "3005334138", "3009888344", "3005737652", "1048735", "9610139", "3009018440", "3015859709", "2523676", "1450662", "3017636737", "8043892", "3004859241", "1000563940", "1649869", "3002244583", "1054811", "3020283264", "1054241", "9680001", "2182269", "3006010712", "3014590708", "1222301", "3030574705", "3014162263", "3003898360", "3008853977", "9681260", "2182208", "1000523114", "3013556777" ], "fei_number": [ "3001632632", "3014656749", "3007113487", "3020968442", "3015489752", "3007146453", "3002468371", "3003407487", "3009211636", "2939520", "3003775027", "3008627763", "3004784537", "3004635528", "2183744", "3024682301", "3030447506", "3007635982", "3016678045", "1000139754", "3011706110", "3000247873", "3003094851", "3010131137", "3013764800", "1293141", "2219920", "3016761372", "3007830707", "3009490946", "3007064586", "3007738736", "2828", "3007361214", "3035642068", "1220452", "3006082230", "3008403546", "3010532612", "3014716786", "3002807725", "3010432890", "3000717902", "3008439199", "1824619", "3002807880", "3008264254", "3018784828", "2183870", "2024024", "1018470", "3003289691", "3002808445", "2518902", "3009121749", "3013750125", "1016427", "3024743081", "2017865", "3007138831", "3009600098", "3014461810", "3002807095", "3030446844", "3013656790", "3011050570", "3008002401", "3002807111", "3010665433", "3004365956", "1028232", "2024168", "3009756153", "3008411636", "3010273872", "3009380063", "3013557562", "3008307705", "3015173212", "3006425876", "3001236905", "3007695959", "3020778", "2024311", "3011564431", "3010291427", "3013023134", "3014499739", "3001124136", "3005012805", "3004111573", "3013611763", "1721504", "2528981", "1000132370", "3009546466", "3030733800", "1221806", "1043214", "3006097687", "3008837339", "3008397795", "1000222374", "3002287318", "3003767881", "3004216185", "1000514656", "3015124694", "3002807314", "3012050423", "3012931345", "2011171", "3000126629", "3042175841", "3003790304", "3002095335", "1000120555", "1000121071", "3002947440", "3009957947", "3004091615", "3005580113", "3002807391", "3012154226", "3009526575", "3012497308", "2126666", "3012159165", "3033589330", "3007284006", "1000112968", "3035372913", "3010163695", "1000123180", "3002917664", "3012536737", "3030452144", "1417485", "3000268902", "3008114965", "3010041511", "3015531723", "2020394", "1282497", "3006950086", "3005846326", "1721676", "3003915875", "3002710305", "3003084417", "3006891611", "3004605321", "3014222368", "3002808331", "3014246639", "3004748528", "3000335778", "1047429", "2025587", "3017961114", "1000121056", "3009564766", "3002806565", "1030451", "1000112877", "3015453963", "3007628272", "3017210488", "3008363989", "1000306431", "1625425", "3008988055", "3039642752", "3010155661", "1721686", "3003737899", "2124215", "1000138054", "3003780911", "1018233", "1000393132", "2521402", "1000220862", "3009039068", "3002913962", "3015309643", "3008061490", "3002808327", "3000206435", "3010419931", "3002806500", "3002808486", "3015550451", "1928237", "3014579161", "3027260597", "3026317086", "3015225571", "3002807439", "1720929", "2245270", "3013943846", "3019751610", "1220477", "3001452571", "3006946276", "3013288201", "3013162291", "3036802499", "1820334", "1319211", "3013666336", "3001451463", "1313046", "1118880", "3015910259", "3020954746", "3014977413", "3005747797", "3002827704", "3000718472", "3012179728", "3016119728", "3014279513", "1000117748", "1000512168", "2527072", "3005334138", "3009888344", "3005737652", "1048735", "3009018440", "3015859709", "2523676", "1450662", "3017636737", "3004859241", "1000563940", "3002244583", "3020283264", "2182269", "3002808050", "3006010712", "3014590708", "1000114185", "3030574705", "3014162263", "3003898360", "3008853977", "3002902735", "2182208", "1000523114", "3013556777" ], "device_name": "Wire, Guide, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1330", "device_class": "2" }, "zip_code": "55311", "applicant": "Boston Scientific", "decision_date": "2018-04-12", "decision_code": "SESE", "country_code": "US", "device_name": "JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire", "advisory_committee": "CV", "contact": "Nikki M. Ibis", "expedited_review_flag": "", "k_number": "K180795", "state": "MN", "date_received": "2018-03-27", "review_advisory_committee": "CV", "postal_code": "55311", "decision_description": "Substantially Equivalent", "clearance_type": "Special" } ] }