{
  "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": "Ann Arbor",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "6200 Jackson Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DWB",
      "openfda": {
        "registration_number": [
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          "3042990265",
          "1828100"
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          "3001589655",
          "3042990265",
          "1828100"
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        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4370",
        "device_class": "2"
      },
      "zip_code": "48103",
      "applicant": "Terumo Cardiovascular Systems Corporation",
      "decision_date": "2013-09-27",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST",
      "advisory_committee": "CV",
      "contact": "JOHN  CHESNEY",
      "expedited_review_flag": "",
      "k_number": "K131618",
      "state": "MI",
      "date_received": "2013-06-03",
      "review_advisory_committee": "CV",
      "postal_code": "48103",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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  ]
}