{
  "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": "Statement",
      "product_code": "DTZ",
      "openfda": {
        "registration_number": [
          "9617601",
          "3009507273",
          "2916596",
          "3019807891",
          "1220648",
          "3008307705",
          "2184009",
          "8010762",
          "3011554160",
          "3003752502",
          "1124841",
          "2528981",
          "9680841",
          "1319639",
          "3014990448",
          "3002806603",
          "2011171",
          "3010155661",
          "3016746283",
          "3005941719",
          "1218444",
          "3013267343",
          "1625519",
          "3002807090",
          "1643817",
          "3010163695",
          "8010026",
          "9681834",
          "3030125051",
          "1928237"
        ],
        "fei_number": [
          "3006003617",
          "3002807111",
          "3000204839",
          "3009507273",
          "2916596",
          "3019807891",
          "1220648",
          "3008307705",
          "3011554160",
          "3003752502",
          "2528981",
          "2828",
          "3009649876",
          "3014990448",
          "3002806603",
          "2011171",
          "3010155661",
          "3016746283",
          "1218444",
          "3005426550",
          "1000138054",
          "3013267343",
          "1625519",
          "1000116158",
          "1643817",
          "3002534070",
          "3002808327",
          "3010163695",
          "3030125051",
          "1928237"
        ],
        "device_name": "Oxygenator, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4350",
        "device_class": "2"
      },
      "zip_code": "55428",
      "applicant": "Medtronic, Inc.",
      "decision_date": "2019-03-18",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)",
      "advisory_committee": "CV",
      "contact": "Tyler  Senjem",
      "expedited_review_flag": "",
      "k_number": "K183511",
      "state": "MN",
      "date_received": "2018-12-18",
      "review_advisory_committee": "CV",
      "postal_code": "55428",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}