{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Newport Beach",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "20250 Acacia St., Suite 115",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DXE",
      "openfda": {
        "registration_number": [
          "3012050423",
          "2024311",
          "3008496528",
          "3013666218",
          "2183744",
          "1721686",
          "2015691",
          "1220452",
          "2183870",
          "9615817",
          "3030714660",
          "9617465",
          "8043983",
          "1220948",
          "2522007",
          "1721504",
          "9680794",
          "3005704822",
          "1000393132",
          "3032916632",
          "3035111606",
          "2027111",
          "3009051888",
          "1820334",
          "3006082230",
          "2648045",
          "3011137372",
          "1319639",
          "1018233",
          "3015859709",
          "1061124",
          "2029386",
          "3010041511"
        ],
        "fei_number": [
          "3012050423",
          "2024311",
          "3008496528",
          "3013666218",
          "2183744",
          "1721686",
          "2015691",
          "3016261803",
          "1220452",
          "2183870",
          "1000306647",
          "1000512168",
          "3003769549",
          "3030714660",
          "1000138054",
          "1220948",
          "2522007",
          "1721504",
          "3005704822",
          "1000393132",
          "3032916632",
          "3035111606",
          "2027111",
          "3003081151",
          "3009051888",
          "1820334",
          "3006082230",
          "2648045",
          "1018233",
          "3015859709",
          "3005747797",
          "3010041511",
          "3003737899"
        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      },
      "zip_code": "92660",
      "applicant": "Sunscope Intl., Inc.",
      "decision_date": "1998-09-04",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "BIOSENSORS EMBOLECTOMY CATHETER",
      "advisory_committee": "CV",
      "contact": "JOHN  SHULZE",
      "expedited_review_flag": "",
      "k_number": "K973477",
      "state": "CA",
      "date_received": "1997-09-15",
      "review_advisory_committee": "CV",
      "postal_code": "92660",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}