{
  "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": "Mounds View",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "8200 Coral Sea St. N.E",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QWF",
      "openfda": {
        "device_name": "Tubing, Long Term Support Greater Than 6 Hours",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4100",
        "device_class": "2",
        "registration_number": [
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          "3030191221",
          "9617601",
          "3002845651",
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          "9611665"
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      "zip_code": "55112",
      "applicant": "Medtronic, Inc.",
      "decision_date": "2023-04-19",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface",
      "advisory_committee": "CV",
      "contact": "Anna  Wetherille",
      "expedited_review_flag": "",
      "k_number": "K223168",
      "state": "MN",
      "date_received": "2022-10-11",
      "review_advisory_committee": "CV",
      "postal_code": "55112",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}