{
  "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",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "PQK",
      "openfda": {
        "k_number": [
          "K183615",
          "K181725",
          "K192239",
          "K182796",
          "DEN170004",
          "DEN160006",
          "K191114"
        ],
        "registration_number": [
          "9616666",
          "2183870",
          "2020394",
          "2030624",
          "2183744"
        ],
        "fei_number": [
          "3000206435",
          "2183870",
          "2020394",
          "3008906816",
          "2183744"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.",
      "regulation_number": "870.1252",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}