{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Raleigh",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "5856 Farington Pl., Suite 200",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PLA",
      "openfda": {
        "device_name": "Esophageal Thermal Regulation And Gastric Suctioning Device",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5910",
        "device_class": "2",
        "registration_number": [
          "3003477135",
          "3010412492"
        ],
        "fei_number": [
          "3003477135",
          "3010412492"
        ]
      },
      "zip_code": "27609",
      "applicant": "Arctx Medical",
      "decision_date": "2025-10-30",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Arctx Cool Catheter Set",
      "advisory_committee": "CV",
      "contact": "Don  Gurskis",
      "expedited_review_flag": "",
      "k_number": "K250632",
      "state": "NC",
      "date_received": "2025-03-03",
      "review_advisory_committee": "CV",
      "postal_code": "27609",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}