{
  "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": "Fairfield",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "15 Law Dr.",
      "address_2": "",
      "statement_or_summary": "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": "07004",
      "applicant": "Datascope Corp.",
      "decision_date": "2013-12-12",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES",
      "advisory_committee": "CV",
      "contact": "LINDA  SLUTZKY",
      "expedited_review_flag": "",
      "k_number": "K133074",
      "state": "NJ",
      "date_received": "2013-09-30",
      "review_advisory_committee": "CV",
      "postal_code": "07004",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}