{
  "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": "Reading",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "3000 Bernville Rd.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "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": "19605",
      "applicant": "Arrow Intl., Inc.",
      "decision_date": "1996-05-15",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)",
      "advisory_committee": "CV",
      "contact": "THOMAS D NICKEL",
      "expedited_review_flag": "",
      "k_number": "K960713",
      "state": "PA",
      "date_received": "1996-02-21",
      "review_advisory_committee": "CV",
      "postal_code": "19605",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}