{
  "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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    {
      "third_party_flag": "N",
      "city": "Englewood",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "14 Inverness Dr. E, Suite H-136",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DXF",
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        "device_name": "Catheter, Septostomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5175",
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      "zip_code": "80112",
      "applicant": "Circa Scientific, Inc.",
      "decision_date": "2024-09-26",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W,  CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)",
      "advisory_committee": "CV",
      "contact": "Jennifer  Willner",
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      "k_number": "K241414",
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      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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