{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Galway",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "Gmit Innovation In Business Centre, Dublin Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MSD",
      "openfda": {
        "device_name": "Catheter, Hemodialysis, Implanted",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5540",
        "device_class": "2",
        "registration_number": [
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      },
      "zip_code": "H91 DCH9",
      "applicant": "Marvao Medical Devices, Ltd.",
      "decision_date": "2018-02-08",
      "decision_code": "SESK",
      "country_code": "IE",
      "device_name": "NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)",
      "advisory_committee": "GU",
      "contact": "Christopher  Davey",
      "expedited_review_flag": "",
      "k_number": "K173805",
      "state": "",
      "date_received": "2017-12-15",
      "review_advisory_committee": "GU",
      "postal_code": "H91 DCH9",
      "decision_description": "Unknown",
      "clearance_type": "Traditional"
    }
  ]
}