{
  "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": "Santa Clara",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "5403 Betsy Ross Dr.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PPN",
      "openfda": {
        "registration_number": [
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          "3009018440",
          "3010273872",
          "2030624",
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        "device_name": "Percutaneous Catheter, Ultrasound",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1250",
        "device_class": "2"
      },
      "zip_code": "95054",
      "applicant": "Shockwave Medical, Inc.",
      "decision_date": "2024-03-22",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter",
      "advisory_committee": "CV",
      "contact": "Anna  Bushart",
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      "k_number": "K240225",
      "state": "CA",
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      "postal_code": "95054",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
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}