{
  "format": "devicerts.device.v1",
  "cite_as": "DABRA Laser System RA-308, Catheter Precision, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/dabra-laser-system-ra-308 (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/dabra-laser-system-ra-308.json",
    "markdown_url": "https://devicerts.com/devices/dabra-laser-system-ra-308.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
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      {
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        "url": "https://open.fda.gov/apis/device/recall/"
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    "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/dabra-laser-system-ra-308",
    "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": "DABRA Laser System RA-308",
    "registry_name": "DABRA Laser System RA-308",
    "url": "https://devicerts.com/devices/dabra-laser-system-ra-308",
    "manufacturer": {
      "name": "Catheter Precision, Inc",
      "url": "https://devicerts.com/manufacturers/catheter-precision-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00842362100024",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K170349",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
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    ],
    "product_codes": [
      "PDU"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "60389",
        "term": "Atherectomy excimer laser system"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00842362100024",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2017-10-13",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K170349",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-05-24",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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    {
      "number": "Z-0569-2021",
      "classification": "Class II",
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      "initiated": "2020-10-16",
      "reason": "Due to footswitch not meeting required specification for protection from ingress of solids or liquids.  If spilling of liquids near or on the footswitch, it may fail in the 'on' position and allow the laser to continue to lase.",
      "applies": "this device",
      "via": "K170349"
    },
    {
      "number": "Z-0050-2021",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2020-07-24",
      "reason": "Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.",
      "applies": "this device",
      "via": "K170349"
    },
    {
      "number": "Z-2497-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2020-01-23",
      "reason": "A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (radiation) may occur, injuring the user or patient.",
      "applies": "this device",
      "via": "K170349"
    },
    {
      "number": "Z-2006-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-09-19",
      "reason": "The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.",
      "applies": "this device",
      "via": "K170349"
    },
    {
      "number": "Z-2218-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-02-15",
      "reason": "Lasers/Catheters did not calibrate during set-up prior to use.",
      "applies": "this device",
      "via": "K170349"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
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        {
          "label": "Trade name",
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                "FDA GUDID (AccessGUDID)"
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            }
          ]
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        {
          "label": "Model / reference",
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          ]
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        {
          "label": "510(k) Number",
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            {
              "value": "K170349",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
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        {
          "label": "GMDN term",
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              "value": "Atherectomy excimer laser system",
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          ]
        }
      ]
    },
    {
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        {
          "label": "Device class",
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            {
              "value": "Class II",
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        {
          "label": "Regulation number",
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            {
              "value": "870.1250",
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        {
          "label": "GUDID distribution status",
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                "FDA GUDID (AccessGUDID)"
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    {
      "group": "Properties",
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        {
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        {
          "label": "Contains latex",
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        {
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        {
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        {
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}