{
  "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": "Morrisville",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "(Subsidiary Of Teleflex Incorporated)",
      "address_2": "3015 Carrington Mill Blvd.",
      "statement_or_summary": "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": "27560",
      "applicant": "Arrow International, LLC",
      "decision_date": "2025-03-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AC3™ Range™ Intra-Aortic Balloon Pump",
      "advisory_committee": "CV",
      "contact": "Apurva  Gokhale",
      "expedited_review_flag": "",
      "k_number": "K250542",
      "state": "NC",
      "date_received": "2025-02-24",
      "review_advisory_committee": "CV",
      "postal_code": "27560",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}