{
  "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": "Mansfield",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "15 Hampshire St.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MPB",
      "openfda": {
        "device_name": "Catheter, Hemodialysis, Non-Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2",
        "registration_number": [
          "3010882065",
          "3014656749",
          "9617592",
          "3010041511",
          "3006425876",
          "3009211636",
          "2030624",
          "1820334",
          "1282497",
          "3004784537",
          "3007544634",
          "1721676",
          "3003915875",
          "3004134316",
          "3000247873",
          "3010131137",
          "3011137372",
          "3006621386",
          "3035111606",
          "9680794",
          "1319639",
          "3006082230",
          "2527072",
          "3009888344",
          "1061124",
          "3015859709",
          "3007137787",
          "3006260740",
          "3012050423",
          "8041145",
          "2011171",
          "1000563940",
          "1018233",
          "2518902",
          "3003661577",
          "3030574705",
          "1722746",
          "9610849",
          "3007836437"
        ],
        "fei_number": [
          "3014656749",
          "3010041511",
          "3002468371",
          "3006425876",
          "3009211636",
          "1820334",
          "1282497",
          "3004784537",
          "3007544634",
          "1721676",
          "3003915875",
          "3004134316",
          "3000247873",
          "3010131137",
          "3005747797",
          "3006621386",
          "3035111606",
          "1000512168",
          "3006097687",
          "3006082230",
          "2527072",
          "3009888344",
          "1000306216",
          "3015859709",
          "3007137787",
          "3006260740",
          "3012050423",
          "2011171",
          "1000563940",
          "3003737899",
          "1000138054",
          "3002974635",
          "1018233",
          "3002807391",
          "2518902",
          "3003661577",
          "3030574705",
          "3000206435",
          "3007836437"
        ]
      },
      "zip_code": "02048",
      "applicant": "Covidien, LLC",
      "decision_date": "2020-01-17",
      "decision_code": "SEKD",
      "country_code": "US",
      "device_name": "Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter",
      "advisory_committee": "GU",
      "contact": "Carol S Ming",
      "expedited_review_flag": "",
      "k_number": "K192302",
      "state": "MA",
      "date_received": "2019-08-23",
      "review_advisory_committee": "GU",
      "postal_code": "02048",
      "decision_description": "Unknown",
      "clearance_type": "Traditional"
    }
  ]
}