{
  "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": "Oakland",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "3 Fir Ct.",
      "address_2": "P.O. Box 3100",
      "statement_or_summary": "",
      "product_code": "DSP",
      "openfda": {
        "registration_number": [
          "2032677",
          "3008496839",
          "3010041511",
          "3013162291",
          "3007965489",
          "3013320573",
          "3003263092",
          "3024894463",
          "2183744",
          "2518435",
          "9680794",
          "1319639",
          "3009077524",
          "2031093",
          "9610816",
          "3010532612",
          "1061124",
          "3015859709",
          "2248146",
          "3002807314",
          "3013596024",
          "2011171",
          "3000126629",
          "3010155661",
          "3013500228",
          "9681477",
          "2249723",
          "2126666"
        ],
        "fei_number": [
          "3008496839",
          "3010041511",
          "3013162291",
          "3007965489",
          "3013320573",
          "3003263092",
          "3024894463",
          "2183744",
          "3002807167",
          "1000512168",
          "2518435",
          "1000222374",
          "3009077524",
          "3010532612",
          "3015859709",
          "3002807314",
          "3013596024",
          "2011171",
          "3000126629",
          "3010155661",
          "3013500228",
          "3003737899",
          "1000138054",
          "3003945344",
          "3001418283",
          "2126666",
          "3001236549",
          "3002807439"
        ],
        "device_name": "System, Balloon, Intra-Aortic And Control",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3535",
        "device_class": "2"
      },
      "zip_code": "07436",
      "applicant": "Datascope Corp.",
      "decision_date": "1985-08-22",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO",
      "advisory_committee": "CV",
      "contact": "STEVE  KONTOS",
      "expedited_review_flag": "",
      "k_number": "K850482",
      "state": "NJ",
      "date_received": "1985-02-07",
      "review_advisory_committee": "CV",
      "postal_code": "07436",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}