{
  "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": {
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    {
      "third_party_flag": "N",
      "city": "Chagrin Falls",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "34 S. Main St., Suite 200",
      "address_2": "",
      "statement_or_summary": "",
      "product_code": "QXU",
      "openfda": {
        "device_name": "Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5710",
        "device_class": "2",
        "registration_number": [
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      "applicant": "S4 Medical Corp.",
      "decision_date": "2023-09-06",
      "decision_code": "DENG",
      "country_code": "US",
      "device_name": "esolution",
      "advisory_committee": "CV",
      "contact": "William  Fuller",
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      "k_number": "DEN230006",
      "state": "OH",
      "date_received": "2023-01-24",
      "review_advisory_committee": "CV",
      "postal_code": "44022",
      "decision_description": "Unknown",
      "clearance_type": "Direct"
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}