{
  "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,
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    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "San Juan Capistrano",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "27123 Calle Arroyo, Suite 2101",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PQK",
      "openfda": {
        "registration_number": [
          "9616666",
          "2183870",
          "2020394",
          "2030624",
          "2183744"
        ],
        "fei_number": [
          "3000206435",
          "2183870",
          "2020394",
          "3008906816",
          "2183744"
        ],
        "device_name": "Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1252",
        "device_class": "2"
      },
      "zip_code": "92675",
      "applicant": "Avenu Medical, Inc.",
      "decision_date": "2018-10-05",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)",
      "advisory_committee": "CV",
      "contact": "Rebecca K. Pine",
      "expedited_review_flag": "",
      "k_number": "K181725",
      "state": "CA",
      "date_received": "2018-06-29",
      "review_advisory_committee": "CV",
      "postal_code": "92675",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}