{
  "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": "2026-07-20",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Plymouth",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "5010 Cheshire Pkwy. N.",
      "address_2": "Suite 2",
      "statement_or_summary": "Summary",
      "product_code": "OWQ",
      "openfda": {
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      "applicant": "Sterilmed, Inc.",
      "decision_date": "2026-06-29",
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      "device_name": "Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)",
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      "contact": "Rachel  Poltilove",
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      "k_number": "K254149",
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