{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Sunnyvale",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "650 Almanor Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NCX",
      "openfda": {
        "registration_number": [
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          "2029275",
          "3029871637",
          "3010617000"
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          "3029871637",
          "1000306431",
          "2024311"
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        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
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      "zip_code": "94085",
      "applicant": "Zoll Circulation",
      "decision_date": "2010-10-12",
      "decision_code": "SESU",
      "country_code": "US",
      "device_name": "COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593",
      "advisory_committee": "CV",
      "contact": "SAM  NANAVATI",
      "expedited_review_flag": "",
      "k_number": "K101987",
      "state": "CA",
      "date_received": "2010-07-14",
      "review_advisory_committee": "NE",
      "postal_code": "94085",
      "decision_description": "Unknown",
      "clearance_type": "Traditional"
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}