{
  "format": "devicerts.device.v1",
  "cite_as": "Percutaneous Introducers, Davol Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/percutaneous-introducers-dyb (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/percutaneous-introducers-dyb",
    "json_url": "https://devicerts.com/devices/percutaneous-introducers-dyb.json",
    "markdown_url": "https://devicerts.com/devices/percutaneous-introducers-dyb.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/percutaneous-introducers-dyb",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Percutaneous Introducers",
    "registry_name": "PERCUTANEOUS INTRODUCERS",
    "url": "https://devicerts.com/devices/percutaneous-introducers-dyb",
    "manufacturer": {
      "name": "Davol Inc.",
      "url": "https://devicerts.com/manufacturers/davol-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K903530",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "DYB"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Percutaneous Introducers are sterile, single-use medical devices designed for vascular access. They facilitate the insertion of catheters, guidewires, or other intravascular devices into the bloodstream through a small incision in the skin, enabling procedures such as angiography, hemodialysis, or pacemaker implantation.\n\nThese devices are supplied as sterile, disposable instruments and are intended for use in clinical settings such as hospitals and outpatient care facilities. They are classified under FDA product code DYB and were granted a Traditional 510(k) clearance in 1990, with a decision of Substantially Equivalent by the Cardiovascular Advisory Committee. No additional regulatory status beyond the stated FDA_510K authorization is implied.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K903530",
      "number_label": null,
      "device_udi_di": null,
      "date": "1990-10-22",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K903530",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "DYB",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 870.1340",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Cardiovascular",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}