{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QXU",
      "openfda": {
        "k_number": [
          "K243233",
          "DEN230006"
        ],
        "registration_number": [
          "3019622578",
          "9613662"
        ],
        "fei_number": [
          "3019622578",
          "3002919051"
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      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or   a specific adverse event during cardiac ablation procedures. The device uses mechanical means to   deviate the esophagus away from the source of ablation energy",
      "regulation_number": "870.5710",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}