{
  "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": "Irvin",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "33 Technology Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MTD",
      "openfda": {
        "registration_number": [
          "9673241",
          "2183787",
          "3010273872",
          "3019807891",
          "1721676",
          "3038966633",
          "2183744",
          "3011276773",
          "1650907",
          "3008452825",
          "3016678045",
          "3013300026",
          "3013627970",
          "3017060084",
          "3013403214",
          "3012179728",
          "2032112",
          "3014279513",
          "3005334138",
          "3009888344",
          "2030404",
          "3011610434",
          "2184149",
          "1721686",
          "2124215",
          "2182269",
          "3004450679",
          "3008093809",
          "3013581838",
          "1928237"
        ],
        "fei_number": [
          "2183787",
          "3010273872",
          "3019807891",
          "1721676",
          "3038966633",
          "2183744",
          "3011276773",
          "3002681132",
          "3008452825",
          "3016678045",
          "3013300026",
          "3003248396",
          "1000139754",
          "3013627970",
          "3017060084",
          "3013403214",
          "3003076831",
          "3012179728",
          "3014279513",
          "3005334138",
          "3009888344",
          "1000519796",
          "3011610434",
          "1721686",
          "2124215",
          "2182269",
          "3004450679",
          "3008093809",
          "3013581838",
          "1928237"
        ],
        "device_name": "Catheter, Intracardiac Mapping, High-Density Array",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1220",
        "device_class": "2"
      },
      "zip_code": "92618",
      "applicant": "Biosense Webster, Inc.",
      "decision_date": "2020-07-31",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Carto Octaray Mapping Catheter with Trueref Technology",
      "advisory_committee": "CV",
      "contact": "Richard  Lauhead",
      "expedited_review_flag": "",
      "k_number": "K193237",
      "state": "CA",
      "date_received": "2019-11-25",
      "review_advisory_committee": "CV",
      "postal_code": "92618",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}