{
  "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",
      "city": "Irvine",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "(Part Of Johnson&Johnson Family Of Companies)",
      "address_2": "31 Technology Dr., Suite 200",
      "statement_or_summary": "Summary",
      "product_code": "OBJ",
      "openfda": {
        "registration_number": [
          "3006985147",
          "3008496839",
          "2531814",
          "2939520",
          "3038966633",
          "3012127758",
          "3016678045",
          "3014272734",
          "3023245",
          "3011137372",
          "3017060084",
          "3005403518",
          "2032112",
          "3009490946",
          "3007738736",
          "3033508292",
          "2090040",
          "3013944123",
          "1058584",
          "1061124",
          "3010432890",
          "9617277",
          "2032350",
          "3011763071",
          "9681834",
          "3003493679",
          "3031397684",
          "3014745562",
          "3010273872",
          "3016171942",
          "3005877899",
          "9710602",
          "2030624",
          "3007695959",
          "3017894900",
          "2024311",
          "3008452825",
          "3013300026",
          "1000601180",
          "2518586",
          "3038718997",
          "3008516548",
          "9680794",
          "3015551113",
          "3010398867",
          "3019216",
          "1225687",
          "3000126629",
          "2011171",
          "3033527241",
          "3011416394",
          "9610482",
          "3013734919",
          "3012833053",
          "3015276088",
          "3017461134",
          "9673241",
          "3009537152",
          "3010041511",
          "3019807891",
          "9612283",
          "3013403214",
          "8043817",
          "3008363989",
          "3032807464",
          "3011610434",
          "2124215",
          "3033527283",
          "3002619337",
          "3013844297",
          "8010026",
          "3003594449",
          "3008497357",
          "3012198618",
          "3013162291",
          "2134243",
          "3005467144",
          "3012179728",
          "2029275",
          "3009077524",
          "2134265",
          "3005334138",
          "3009888344",
          "3009196578",
          "2030404",
          "3015859709",
          "3016076141",
          "3010952312",
          "2182269",
          "3009350690",
          "3003898360"
        ],
        "fei_number": [
          "3006985147",
          "3008496839",
          "2939520",
          "3038966633",
          "3012127758",
          "3016678045",
          "3014272734",
          "3023245",
          "3017060084",
          "3005403518",
          "3009490946",
          "3007738736",
          "2828",
          "3033508292",
          "3013944123",
          "3010432890",
          "3002626007",
          "3002808529",
          "3011763071",
          "3003493679",
          "3031397684",
          "3014745562",
          "3010273872",
          "3016171942",
          "3005877899",
          "3017894900",
          "3007695959",
          "2024311",
          "3008452825",
          "3013300026",
          "1000601180",
          "2518586",
          "3038718997",
          "3008516548",
          "3015551113",
          "3003190524",
          "3010398867",
          "3019216",
          "3000126629",
          "2011171",
          "3002095335",
          "3033527241",
          "3011416394",
          "3013734919",
          "3012833053",
          "3015276088",
          "3017461134",
          "3009537152",
          "3010041511",
          "3019807891",
          "3003513129",
          "3013403214",
          "3003076831",
          "3008363989",
          "3003309342",
          "1000306431",
          "3032807464",
          "3011610434",
          "3003737899",
          "2124215",
          "3033527283",
          "3002619337",
          "3002808327",
          "3002808457",
          "3013844297",
          "3000206435",
          "3003594449",
          "3008497357",
          "3012198618",
          "3013162291",
          "3003094575",
          "3001451463",
          "3005467144",
          "3003248396",
          "1000219637",
          "3005747797",
          "3012179728",
          "1000512168",
          "3009077524",
          "3001726808",
          "3005334138",
          "3009888344",
          "3009196578",
          "1000519796",
          "3002615969",
          "3015859709",
          "3016076141",
          "3010952312",
          "2182269",
          "3009350690",
          "3003898360"
        ],
        "device_name": "Catheter, Ultrasound, Intravascular",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.1200",
        "device_class": "2"
      },
      "zip_code": "92618",
      "applicant": "Biosense Webster, Inc.",
      "decision_date": "2024-06-28",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter",
      "advisory_committee": "CV",
      "contact": "Sheba  Chacko",
      "expedited_review_flag": "",
      "k_number": "K241540",
      "state": "CA",
      "date_received": "2024-05-31",
      "review_advisory_committee": "CV",
      "postal_code": "92618",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}