{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Montreal",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "2300 Blvd. Alfred Nobel",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PDU",
      "openfda": {
        "registration_number": [
          "3002807314",
          "3009882464",
          "3008729892",
          "2020394",
          "3009128730",
          "1722746",
          "3007284006",
          "3023527320",
          "2030598",
          "3005580113",
          "3027058844",
          "3009018440",
          "1016427",
          "3009561706",
          "3009039068",
          "2939520",
          "1450662",
          "3003637635",
          "2528981",
          "1724474",
          "1018233",
          "1820334",
          "3008789872",
          "2183870",
          "9616099",
          "3000126629",
          "3013757884",
          "3008363989",
          "1221485",
          "3038165043",
          "1319639",
          "3020968442",
          "3008998256",
          "3006082230",
          "2011171",
          "1721676",
          "3030446844",
          "3010273872",
          "2183744",
          "1643817",
          "1313046",
          "2126666"
        ],
        "fei_number": [
          "3002807314",
          "3009882464",
          "2020394",
          "3009128730",
          "3007284006",
          "3023527320",
          "3005580113",
          "3027058844",
          "3009018440",
          "3003528016",
          "1016427",
          "3009561706",
          "3009039068",
          "2939520",
          "1450662",
          "3003637635",
          "2528981",
          "3002807555",
          "1018233",
          "1000138054",
          "3003094851",
          "1820334",
          "3008789872",
          "2183870",
          "3000126629",
          "3013757884",
          "3038165043",
          "3008363989",
          "1221485",
          "3020968442",
          "3008998256",
          "1000306216",
          "3006082230",
          "1000518731",
          "2011171",
          "1721676",
          "3030446844",
          "3010273872",
          "2183744",
          "1643817",
          "1313046",
          "2126666"
        ],
        "device_name": "Catheter For Crossing Total Occlusions",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      },
      "zip_code": "H4S 2A4",
      "applicant": "Soundbite Medical Solution, Inc.",
      "decision_date": "2020-01-17",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "SoundBite Console, SoundBite Active Wire 18",
      "advisory_committee": "CV",
      "contact": "Marc Andre Cote",
      "expedited_review_flag": "",
      "k_number": "K192211",
      "state": "",
      "date_received": "2019-08-14",
      "review_advisory_committee": "CV",
      "postal_code": "H4S 2A4",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}