{
  "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": 9
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Shenzhen",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "#1 Jinkui Rd., Futian Free Trade Zone",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LOX",
      "openfda": {
        "registration_number": [
          "3008002401",
          "9617601",
          "1028232",
          "2024168",
          "3010273872",
          "3006946276",
          "3010220595",
          "2939561",
          "9710284",
          "3019807891",
          "3009205152",
          "9612164",
          "3008700817",
          "3024893679",
          "3011564431",
          "3012693555",
          "2183744",
          "1313046",
          "3008573567",
          "3016678045",
          "3030421123",
          "3009965866",
          "3010131137",
          "3008824097",
          "3011137372",
          "3014222368",
          "3006550224",
          "3015910259",
          "3013634084",
          "2134812",
          "3016761372",
          "3015002281",
          "3017961114",
          "1000121056",
          "3035111606",
          "3009564766",
          "3043534762",
          "1319639",
          "2134265",
          "3006513822",
          "3015453963",
          "3030236028",
          "3010432890",
          "1225687",
          "3009018440",
          "8043892",
          "3034695832",
          "3002807314",
          "3012050423",
          "2011171",
          "1721686",
          "3010391265",
          "2124215",
          "3012167431",
          "3003775186",
          "3004415014",
          "3013152301",
          "3031550970",
          "3003084171",
          "3004091615",
          "3002807315",
          "3017262662",
          "3014390222",
          "3014461810",
          "9681260",
          "3004824117",
          "3007836437",
          "8010026",
          "9681834",
          "9614654",
          "3009613036",
          "3013546453"
        ],
        "fei_number": [
          "3008002401",
          "1028232",
          "2024168",
          "3010273872",
          "3006946276",
          "3010220595",
          "3019807891",
          "3009205152",
          "3008700817",
          "3024893679",
          "3011564431",
          "3004635528",
          "3012693555",
          "2183744",
          "3001451463",
          "3003182398",
          "3008573567",
          "3016678045",
          "3030421123",
          "3009965866",
          "1313046",
          "3010131137",
          "3008824097",
          "3014222368",
          "3006550224",
          "3015910259",
          "3013634084",
          "3005747797",
          "3016761372",
          "3002827704",
          "3015002281",
          "3002808904",
          "3017961114",
          "1000121056",
          "3035111606",
          "3009564766",
          "3002806565",
          "3043534762",
          "2828",
          "3006513822",
          "3015453963",
          "3030236028",
          "3010432890",
          "3009018440",
          "3034695832",
          "3002807314",
          "3012050423",
          "2011171",
          "1721686",
          "3010391265",
          "1000138054",
          "2124215",
          "3012167431",
          "3003775186",
          "3002095335",
          "3004415014",
          "3002808050",
          "3013152301",
          "3031550970",
          "3003084171",
          "3004091615",
          "3002807315",
          "3017262662",
          "3002806434",
          "3014390222",
          "3002534070",
          "3002808327",
          "3014461810",
          "3004824117",
          "3007836437",
          "3009613036",
          "3013546453"
        ],
        "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5100",
        "device_class": "2"
      },
      "zip_code": "518038",
      "applicant": "OrbusNeich Medical (Shenzhen) Co., Ltd.",
      "decision_date": "2021-10-14",
      "decision_code": "SESE",
      "country_code": "CN",
      "device_name": "Sapphire NC 24",
      "advisory_committee": "CV",
      "contact": "Daniel  Zhang",
      "expedited_review_flag": "",
      "k_number": "K211807",
      "state": "",
      "date_received": "2021-06-11",
      "review_advisory_committee": "CV",
      "postal_code": "518038",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}