{
  "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": 2
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Suzhou",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "Bldg. B9 Unit 201, # 218 Xinghu Rd., Sip",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "KRA",
      "openfda": {
        "registration_number": [
          "",
          "3027395815",
          "3007156625",
          "3003120897",
          "3010421104",
          "9617594",
          "3015489145",
          "2029214",
          "2183744",
          "3008824097",
          "3011137372",
          "3006550224",
          "3019525998",
          "2032112",
          "3013858269",
          "1220452",
          "3006082230",
          "1718873",
          "3002806337",
          "3008264254",
          "2022435",
          "2183870",
          "9612051",
          "2531321",
          "8020616",
          "1713468",
          "9681834",
          "3014758755",
          "3031823122",
          "3010665433",
          "1047843",
          "3014787927",
          "3032916632",
          "9617601",
          "3009756153",
          "3010273872",
          "3009380063",
          "3031240343",
          "3013557562",
          "3008307705",
          "2030624",
          "3007695959",
          "3013134719",
          "2024311",
          "3016948450",
          "3010047454",
          "3004111573",
          "2244478",
          "9616662",
          "1721504",
          "3009546466",
          "2015691",
          "3030733800",
          "3008837339",
          "1225687",
          "2183319",
          "3002807314",
          "3026567963",
          "3038791046",
          "3000126629",
          "2011171",
          "3017823876",
          "3008881809",
          "3005941719",
          "3012448339",
          "3010173425",
          "1220948",
          "3014498720",
          "3009500972",
          "2529392",
          "3012497308",
          "3015151147",
          "3033589330",
          "3012536737",
          "3030481118",
          "3043337628",
          "3008114965",
          "3010041511",
          "3019807891",
          "1644312",
          "1282497",
          "3006950086",
          "1721676",
          "3023167283",
          "9612501",
          "2246552",
          "3013391155",
          "1000121056",
          "3014211783",
          "9616684",
          "3015453963",
          "3007628272",
          "3017210488",
          "3004142795",
          "1625425",
          "2124215",
          "3004415014",
          "3014779787",
          "1018233",
          "8023054",
          "1000393132",
          "3014687026",
          "3015309643",
          "3031976597",
          "3012307300",
          "1724474",
          "8010026",
          "9615817",
          "3015550451",
          "1928237",
          "3015225571",
          "3010079067",
          "3015924373",
          "1220477",
          "3005160949",
          "3006946276",
          "3010220595",
          "3040801290",
          "2648045",
          "9616567",
          "1820334",
          "1319211",
          "1064858",
          "3020347218",
          "3021067373",
          "3010334444",
          "2134812",
          "3010909876",
          "1319639",
          "2134265",
          "1048735",
          "3027595864",
          "3017636737",
          "3004859241",
          "3012543881",
          "3014590708",
          "3014644549",
          "3016927279",
          "3017208642",
          "3030574705",
          "3014162263",
          "3008853977",
          "3008514120",
          "9681260",
          "2648729",
          "1000523114",
          "3020256033",
          "3013556777"
        ],
        "fei_number": [
          "",
          "3027395815",
          "3003120897",
          "1000136269",
          "3010421104",
          "3003495548",
          "3015489145",
          "2183744",
          "3003094851",
          "3008824097",
          "3006550224",
          "3019525998",
          "3013858269",
          "2828",
          "1220452",
          "3006082230",
          "1718873",
          "3002806337",
          "3008264254",
          "2022435",
          "2183870",
          "1713468",
          "3014758755",
          "3031823122",
          "3010665433",
          "3002807111",
          "1047843",
          "3014787927",
          "3032916632",
          "3002963732",
          "3009756153",
          "3010273872",
          "3009380063",
          "3031240343",
          "3013557562",
          "3008307705",
          "3007695959",
          "3013134719",
          "2024311",
          "3016948450",
          "3010047454",
          "3004111573",
          "1721504",
          "3009546466",
          "2015691",
          "3030733800",
          "3008397795",
          "3008837339",
          "3004216185",
          "2183319",
          "3002807314",
          "3026567963",
          "3038791046",
          "3000126629",
          "2011171",
          "3017823876",
          "3008881809",
          "3012448339",
          "3008133910",
          "3002095335",
          "1220948",
          "3014498720",
          "3009500972",
          "3012497308",
          "3015151147",
          "3033589330",
          "3012536737",
          "3030481118",
          "3043337628",
          "3008114965",
          "3010041511",
          "3019807891",
          "1282497",
          "3006950086",
          "1721676",
          "3023167283",
          "2246552",
          "3002807036",
          "3000335778",
          "3003076831",
          "3013391155",
          "1000121056",
          "3014211783",
          "3002806565",
          "3004142795",
          "3015453963",
          "3007628272",
          "3017210488",
          "1625425",
          "2124215",
          "1000138054",
          "3004415014",
          "3014779787",
          "1018233",
          "3003807466",
          "1000393132",
          "3014687026",
          "1000220862",
          "3015309643",
          "3002913962",
          "3031976597",
          "3002806457",
          "3002534070",
          "3002808327",
          "3000206435",
          "3012307300",
          "3015550451",
          "1928237",
          "3015225571",
          "3010079067",
          "3015924373",
          "1220477",
          "3005160949",
          "3006946276",
          "3010220595",
          "3040801290",
          "2648045",
          "3003081151",
          "1820334",
          "1319211",
          "3002806476",
          "1000121498",
          "3020347218",
          "3001451463",
          "3021067373",
          "3010334444",
          "3005747797",
          "3002827704",
          "1000117748",
          "3010909876",
          "1048735",
          "3001237758",
          "3027595864",
          "3017636737",
          "3004859241",
          "3012543881",
          "3014590708",
          "3014644549",
          "3016927279",
          "3017208642",
          "3030574705",
          "3014162263",
          "3008853977",
          "3008514120",
          "2648729",
          "1000523114",
          "3020256033",
          "3013556777"
        ],
        "device_name": "Catheter, Continuous Flush",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1210",
        "device_class": "2"
      },
      "zip_code": "215126",
      "applicant": "Suzhou Hengrui Hongyuan Medical Co., Ltd.",
      "decision_date": "2022-04-11",
      "decision_code": "SESE",
      "country_code": "CN",
      "device_name": "Micro Catheter and Guidewire System",
      "advisory_committee": "CV",
      "contact": "Wang  Peipei",
      "expedited_review_flag": "",
      "k_number": "K212719",
      "state": "",
      "date_received": "2021-08-27",
      "review_advisory_committee": "CV",
      "postal_code": "215126",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}