{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Eden Prairie",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "12988 Valley View Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NQJ",
      "openfda": {
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          "2183744",
          "3003661577"
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        "device_name": "Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2"
      },
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      "applicant": "Nuwellis, Inc.",
      "decision_date": "2025-08-13",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)",
      "advisory_committee": "GU",
      "contact": "Neil  Ayotte",
      "expedited_review_flag": "",
      "k_number": "K252226",
      "state": "MN",
      "date_received": "2025-07-16",
      "review_advisory_committee": "GU",
      "postal_code": "55344",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
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}