{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QWA",
      "openfda": {
        "registration_number": [
          "3007603855",
          "3030516433",
          "1721676",
          "3017298588",
          "3015179394",
          "3005070406",
          "2015691",
          "2135147",
          "3044322716",
          "3007113487",
          "2939561",
          "2011171",
          "3006128321",
          "3008500478",
          "3005941719",
          "3013596742",
          "3015972835",
          "3004091615"
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        "fei_number": [
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          "3004635528",
          "3030516433",
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          "3015179394",
          "3005070406",
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          "3006128321",
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          "3002807111",
          "3013596742",
          "3015972835",
          "3004091615"
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      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Cardiovascular Delivery Catheter System Positioning And Stabilization Device",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "1",
      "definition": "A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.",
      "regulation_number": "870.3955",
      "implant_flag": "N",
      "submission_type_id": "4"
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  ]
}