{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NTE",
      "openfda": {
        "k_number": [
          "K120480",
          "K042218",
          "K081523",
          "K052166",
          "K082348",
          "K143072",
          "K143570",
          "K072990",
          "K110909",
          "K062531",
          "K200198",
          "K121015",
          "K063313",
          "K103500",
          "K052165",
          "K052659",
          "K111010",
          "K153086",
          "K092177",
          "K230402",
          "K063204",
          "K090665",
          "K101651",
          "K191173",
          "K153485",
          "K220654",
          "K210282",
          "K141678",
          "K083300",
          "K081549",
          "K180023",
          "K052454",
          "K222694",
          "K111987",
          "K042908",
          "K123156"
        ],
        "registration_number": [
          "3022627847",
          "9617601",
          "2024168",
          "2939561",
          "3007695959",
          "3013666336",
          "2183744",
          "3011471056",
          "1000121056",
          "3007738736",
          "1319639",
          "3013944123",
          "3002807314",
          "3004859241",
          "3002806603",
          "2011171",
          "2183870",
          "3012121095",
          "2124215",
          "2024024",
          "3004742232",
          "3004091615",
          "1016427",
          "2126666",
          "3013556777"
        ],
        "fei_number": [
          "3022627847",
          "2024168",
          "3007695959",
          "3004635528",
          "3013666336",
          "2183744",
          "3011471056",
          "1000121056",
          "3007738736",
          "3013944123",
          "3002807314",
          "3004859241",
          "3002806603",
          "2011171",
          "2183870",
          "3012121095",
          "2124215",
          "1000138054",
          "2024024",
          "3004742232",
          "3004091615",
          "1016427",
          "2126666",
          "3002534070",
          "3013556777"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Temporary Carotid Catheter For Embolic Capture",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire.  The catheter has an embolic capture filter or an occlusion balloon at the distal end.  The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae.  The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i",
      "regulation_number": "870.1250",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}