{
  "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": "2026-10-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Newark",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "2035 Sunset Lake Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "KFM",
      "openfda": {
        "registration_number": [
          "2916596",
          "3016746283",
          "1928237",
          "1123137",
          "9681834",
          "3002807090",
          "3044156918",
          "3003306248",
          "3012119238",
          "3008792657",
          "3014990448",
          "3009380063",
          "1828100",
          "2011171",
          "3007427881",
          "9680841",
          "3010163695",
          "3003661577",
          "2184009",
          "2029275",
          "8010026",
          "1218444",
          "3009507273",
          "3005941719",
          "1220648",
          "1422634",
          "3019807891",
          "2528981",
          "3006849754",
          "1124841",
          "3006073153",
          "1319639",
          "3011554160",
          "9617601",
          "3030125051",
          "8010762"
        ],
        "fei_number": [
          "2916596",
          "3002534070",
          "3016746283",
          "1928237",
          "3044156918",
          "1000138054",
          "1000306431",
          "3003306248",
          "3012119238",
          "3008792657",
          "3009649876",
          "3014990448",
          "3009380063",
          "1828100",
          "1000514656",
          "2011171",
          "3007427881",
          "1000116158",
          "3010163695",
          "2828",
          "3005426550",
          "3003661577",
          "3000204839",
          "1218444",
          "3009507273",
          "1220648",
          "3019807891",
          "2528981",
          "3006849754",
          "1000123180",
          "3002807111",
          "3002808327",
          "3006073153",
          "3011554160",
          "3006003617",
          "3030125051"
        ],
        "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4360",
        "device_class": "2"
      },
      "zip_code": "19702",
      "applicant": "Jostra Medizintechnik AG",
      "decision_date": "2000-08-31",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ROTAFLOW CENTRIFUGAL PUMP SYSTEM",
      "advisory_committee": "CV",
      "contact": "KATHY  JOHNSON",
      "expedited_review_flag": "",
      "k_number": "K991864",
      "state": "DE",
      "date_received": "1999-06-01",
      "review_advisory_committee": "CV",
      "postal_code": "19702",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}