{
  "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": "Elkton",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "125 Blue Ball Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "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": "21921",
      "applicant": "Terumo Corp.",
      "decision_date": "2007-07-16",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER",
      "advisory_committee": "CV",
      "contact": "GARY  COURTNEY",
      "expedited_review_flag": "",
      "k_number": "K071494",
      "state": "MD",
      "date_received": "2007-05-30",
      "review_advisory_committee": "CV",
      "postal_code": "21921",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}