{
  "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": "DWE",
      "openfda": {
        "registration_number": [
          "9617601",
          "3009380063",
          "3019807891",
          "2184009",
          "1319211",
          "1721676",
          "3015537049",
          "1718850",
          "1124841",
          "2029275",
          "1043214",
          "1319639",
          "2011171",
          "3005941719",
          "1222928",
          "2520313",
          "3017987980",
          "1724474",
          "1000523114",
          "1928237"
        ],
        "fei_number": [
          "3002807111",
          "3000204839",
          "3009380063",
          "3019807891",
          "1319211",
          "1721676",
          "3003094851",
          "3015537049",
          "1718850",
          "1043214",
          "1000306431",
          "1000120613",
          "2011171",
          "1000138054",
          "2520313",
          "1000116158",
          "3017987980",
          "3002534070",
          "1000523114",
          "1928237"
        ],
        "device_name": "Tubing, Pump, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4390",
        "device_class": "2"
      },
      "zip_code": "21921",
      "applicant": "Terumo Corp.",
      "decision_date": "2000-03-01",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING",
      "advisory_committee": "CV",
      "contact": "GARRY A COURTNEY",
      "expedited_review_flag": "",
      "k_number": "K993189",
      "state": "MD",
      "date_received": "1999-09-23",
      "review_advisory_committee": "CV",
      "postal_code": "21921",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}