{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Everett",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "9 Plymouth St.",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "DSP",
      "openfda": {
        "registration_number": [
          "3002807314",
          "9680794",
          "3015859709",
          "2248146",
          "3008496839",
          "3024894463",
          "3010155661",
          "3013596024",
          "2032677",
          "1061124",
          "3013320573",
          "3013500228",
          "3000126629",
          "3003263092",
          "9610816",
          "1319639",
          "2518435",
          "2249723",
          "3010532612",
          "3009077524",
          "2011171",
          "9681477",
          "3010041511",
          "3013162291",
          "2031093",
          "2183744",
          "2126666",
          "3007965489"
        ],
        "fei_number": [
          "3002807314",
          "3015859709",
          "3008496839",
          "3024894463",
          "3010155661",
          "3013596024",
          "3013320573",
          "1000138054",
          "3013500228",
          "3003945344",
          "3000126629",
          "3003263092",
          "2518435",
          "3002807167",
          "3002807439",
          "3003737899",
          "1000512168",
          "3010532612",
          "3009077524",
          "3001418283",
          "2011171",
          "3010041511",
          "3013162291",
          "2183744",
          "3001236549",
          "1000222374",
          "2126666",
          "3007965489"
        ],
        "device_name": "System, Balloon, Intra-Aortic And Control",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3535",
        "device_class": "2"
      },
      "zip_code": "02149",
      "applicant": "Kontron Instruments, Inc.",
      "decision_date": "1989-09-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON",
      "advisory_committee": "CV",
      "contact": "DAVID  CROMWICK",
      "expedited_review_flag": "",
      "k_number": "K892798",
      "state": "MA",
      "date_received": "1989-04-17",
      "review_advisory_committee": "CV",
      "postal_code": "02149",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}