{
  "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": "Saint Paul",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "651 Campus Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MCW",
      "openfda": {
        "registration_number": [
          "3032916632",
          "3009756153",
          "3003708554",
          "3010273872",
          "3020968442",
          "3006946276",
          "3010041511",
          "2648045",
          "9612164",
          "3012669557",
          "2020394",
          "2939520",
          "3016257349",
          "1721676",
          "2024311",
          "2183744",
          "3000279201",
          "3038165043",
          "3002631703",
          "3010280625",
          "3011137372",
          "2244478",
          "1000121056",
          "2015691",
          "3008814558",
          "9616684",
          "2134265",
          "3008363989",
          "1061124",
          "1225687",
          "1625425",
          "3008439199",
          "3015124694",
          "3002807314",
          "3003862657",
          "3004859241",
          "3000126629",
          "2011171",
          "3017896194",
          "2183870",
          "2124215",
          "3010173425",
          "3003780911",
          "3004742232",
          "3016445722",
          "3004091615",
          "3014443747",
          "3007048256",
          "1643817",
          "3007284006",
          "1724474",
          "3014254831"
        ],
        "fei_number": [
          "3032916632",
          "3009756153",
          "3003708554",
          "3010273872",
          "3020968442",
          "3006946276",
          "3010041511",
          "2648045",
          "3012669557",
          "2020394",
          "1000136269",
          "2939520",
          "3016257349",
          "1721676",
          "2024311",
          "2183744",
          "3000279201",
          "3038165043",
          "3001451463",
          "3002631703",
          "3003094851",
          "3010280625",
          "3002807036",
          "3005747797",
          "1000121056",
          "1000512168",
          "2015691",
          "3008814558",
          "3008363989",
          "1625425",
          "3008439199",
          "3015124694",
          "3002807314",
          "3003862657",
          "3004859241",
          "3000126629",
          "2011171",
          "3017896194",
          "3002095335",
          "2124215",
          "2183870",
          "3003780911",
          "3004742232",
          "3016445722",
          "3004091615",
          "3014443747",
          "3002806434",
          "3002913962",
          "3007048256",
          "1643817",
          "3007284006",
          "3014254831"
        ],
        "device_name": "Catheter, Peripheral, Atherectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4875",
        "device_class": "2"
      },
      "zip_code": "55112",
      "applicant": "Cardiovascular Systems, Inc.",
      "decision_date": "2007-08-30",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS",
      "advisory_committee": "CV",
      "contact": "CINDY  SETUM",
      "expedited_review_flag": "",
      "k_number": "K071427",
      "state": "MN",
      "date_received": "2007-05-23",
      "review_advisory_committee": "CV",
      "postal_code": "55112",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}