{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Minneapolis",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "7611 Northland Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DTM",
      "openfda": {
        "registration_number": [
          "3008500478",
          "9617601",
          "3031571797",
          "3037389071",
          "3008307705",
          "2184009",
          "8010762",
          "3011554160",
          "3005012805",
          "3003752502",
          "1124841",
          "2029275",
          "9680841",
          "1319639",
          "2011171",
          "3003152463",
          "3005941719",
          "3008132398",
          "1625519",
          "3002807090",
          "1643817",
          "1724474",
          "8010026",
          "9681834",
          "1928237"
        ],
        "fei_number": [
          "3006003617",
          "3002807111",
          "3000204839",
          "3031571797",
          "3008307705",
          "3011554160",
          "3003094851",
          "3005012805",
          "3003752502",
          "2828",
          "1713910",
          "3009649876",
          "1000306431",
          "3002807091",
          "2011171",
          "3003152463",
          "3005426550",
          "1000138054",
          "2013342",
          "1625519",
          "1000116158",
          "1643817",
          "3002534070",
          "3002808327",
          "1928237"
        ],
        "device_name": "Filter, Blood, Cardiopulmonary Bypass, Arterial Line",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4260",
        "device_class": "2"
      },
      "zip_code": "55038",
      "applicant": "Medtronic Perfusion Systems",
      "decision_date": "2003-11-14",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE",
      "advisory_committee": "CV",
      "contact": "MICHELE  PYFFEROEN",
      "expedited_review_flag": "",
      "k_number": "K033468",
      "state": "MN",
      "date_received": "2003-11-03",
      "review_advisory_committee": "CV",
      "postal_code": "55038",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}