{
  "companyId": "48134",
  "slug": "medtronic-vascular-48134",
  "name": "Medtronic Vascular",
  "clearances": {
    "total": 480,
    "last12Months": 0,
    "first": "1977-10-28",
    "latest": "2023-10-24"
  },
  "medianReviewDays": 74,
  "productCodeCount": 83,
  "recalls": {
    "total": 234,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1042-2022",
        "productCode": "ONU",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2022-03-23",
        "reason": "Packaging for Balloon Catheters  may be damaged resulting in loss of sterility."
      },
      {
        "resNumber": "Z-1043-2022",
        "productCode": "PRC",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2022-03-23",
        "reason": "Packaging for Balloon Catheters  may be damaged resulting in loss of sterility."
      },
      {
        "resNumber": "Z-0657-2022",
        "productCode": "MIH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2021-12-21",
        "reason": "Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable."
      },
      {
        "resNumber": "Z-0290-2022",
        "productCode": "MIH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2021-10-15",
        "reason": "During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube"
      },
      {
        "resNumber": "Z-0291-2022",
        "productCode": "MIH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2021-10-15",
        "reason": "Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube."
      }
    ]
  },
  "registration": {
    "sites": 2,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DTB",
      "deviceName": "Permanent Pacemaker Electrode",
      "clearances": 69,
      "latest": "2003-05-22",
      "medianReviewDays": 87
    },
    {
      "code": "DXY",
      "deviceName": "Implantable Pacemaker Pulse-Generator",
      "clearances": 59,
      "latest": "1995-12-15",
      "medianReviewDays": 76
    },
    {
      "code": "GZB",
      "deviceName": "Stimulator, Spinal-Cord, Implanted (Pain Relief)",
      "clearances": 56,
      "latest": "2004-03-25",
      "medianReviewDays": 96
    },
    {
      "code": "DQY",
      "deviceName": "Catheter, Percutaneous",
      "clearances": 31,
      "latest": "2023-08-22",
      "medianReviewDays": 44
    },
    {
      "code": "LDF",
      "deviceName": "Electrode, Pacemaker, Temporary",
      "clearances": 21,
      "latest": "2004-09-07",
      "medianReviewDays": 69
    },
    {
      "code": "DTD",
      "deviceName": "Pacemaker Lead Adaptor",
      "clearances": 19,
      "latest": "2000-02-23",
      "medianReviewDays": 64
    },
    {
      "code": "DXH",
      "deviceName": "Transmitters And Receivers, Electrocardiograph, Telephone",
      "clearances": 15,
      "latest": "1992-01-30",
      "medianReviewDays": 37
    },
    {
      "code": "DTZ",
      "deviceName": "Oxygenator, Cardiopulmonary Bypass",
      "clearances": 12,
      "latest": "2000-02-25",
      "medianReviewDays": 99
    },
    {
      "code": "GXY",
      "deviceName": "Electrode, Cutaneous",
      "clearances": 10,
      "latest": "1988-07-18",
      "medianReviewDays": 35
    },
    {
      "code": "GZJ",
      "deviceName": "Stimulator, Nerve, Transcutaneous, For Pain Relief",
      "clearances": 10,
      "latest": "1991-12-10",
      "medianReviewDays": 26
    },
    {
      "code": "GZF",
      "deviceName": "Stimulator, Peripheral Nerve, Implanted (Pain Relief)",
      "clearances": 8,
      "latest": "2000-04-12",
      "medianReviewDays": 89
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 7,
      "latest": "2017-12-20",
      "medianReviewDays": 111
    },
    {
      "code": "DRX",
      "deviceName": "Electrode, Electrocardiograph",
      "clearances": 6,
      "latest": "1993-03-18",
      "medianReviewDays": 65
    },
    {
      "code": "DWF",
      "deviceName": "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",
      "clearances": 6,
      "latest": "2004-01-29",
      "medianReviewDays": 29
    },
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
      "clearances": 5,
      "latest": "2023-10-24",
      "medianReviewDays": 76
    },
    {
      "code": "DSA",
      "deviceName": "Cable, Transducer And Electrode, Patient, (Including Connector)",
      "clearances": 5,
      "latest": "1996-05-22",
      "medianReviewDays": 56
    },
    {
      "code": "DTC",
      "deviceName": "Analyzer, Pacemaker Generator Function",
      "clearances": 5,
      "latest": "1991-05-07",
      "medianReviewDays": 88
    },
    {
      "code": "DTE",
      "deviceName": "Pulse-Generator, Pacemaker, External",
      "clearances": 5,
      "latest": "1997-07-14",
      "medianReviewDays": 40
    },
    {
      "code": "DTN",
      "deviceName": "Reservoir, Blood, Cardiopulmonary Bypass",
      "clearances": 5,
      "latest": "2001-07-09",
      "medianReviewDays": 129
    },
    {
      "code": "IPF",
      "deviceName": "Stimulator, Muscle, Powered",
      "clearances": 5,
      "latest": "1992-05-20",
      "medianReviewDays": 36
    },
    {
      "code": "IYX",
      "deviceName": "Camera, Scintillation (Gamma)",
      "clearances": 5,
      "latest": "1981-05-27",
      "medianReviewDays": 28
    },
    {
      "code": "DSY",
      "deviceName": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
      "clearances": 4,
      "latest": "1991-11-27",
      "medianReviewDays": 83
    },
    {
      "code": "DTM",
      "deviceName": "Filter, Blood, Cardiopulmonary Bypass, Arterial Line",
      "clearances": 4,
      "latest": "2007-07-03",
      "medianReviewDays": 17
    },
    {
      "code": "DTP",
      "deviceName": "Defoamer, Cardiopulmonary Bypass",
      "clearances": 4,
      "latest": "1993-10-15",
      "medianReviewDays": 86
    },
    {
      "code": "DTR",
      "deviceName": "Heat-Exchanger, Cardiopulmonary Bypass",
      "clearances": 4,
      "latest": "2000-12-21",
      "medianReviewDays": 69
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "83",
  "recentClearances": [
    {
      "kNumber": "K232570",
      "deviceName": "Steerant™ Super Stiff Guidewire",
      "productCode": "DQX",
      "decisionDate": "2023-10-24",
      "reviewDays": 61
    },
    {
      "kNumber": "K232190",
      "deviceName": "6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter",
      "productCode": "DQY",
      "decisionDate": "2023-08-22",
      "reviewDays": 29
    },
    {
      "kNumber": "K230156",
      "deviceName": "5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter",
      "productCode": "DQY",
      "decisionDate": "2023-06-30",
      "reviewDays": 162
    },
    {
      "kNumber": "K220773",
      "deviceName": "Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle  (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle,  4. Torque Handle (AC3205P)",
      "productCode": "MAV",
      "decisionDate": "2022-04-13",
      "reviewDays": 28
    },
    {
      "kNumber": "K192296",
      "deviceName": "Medtronic 6F Taiga Guiding Catheter",
      "productCode": "DQY",
      "decisionDate": "2019-09-20",
      "reviewDays": 28
    },
    {
      "kNumber": "K182957",
      "deviceName": "Heli-FX EndoAnchor System",
      "productCode": "OTD",
      "decisionDate": "2018-11-21",
      "reviewDays": 28
    },
    {
      "kNumber": "K173515",
      "deviceName": "Admiral Xtreme",
      "productCode": "LIT",
      "decisionDate": "2018-04-12",
      "reviewDays": 149
    },
    {
      "kNumber": "K171866",
      "deviceName": "Sentrant Introducer Sheath with Hydrophilic Coating",
      "productCode": "DYB",
      "decisionDate": "2017-12-20",
      "reviewDays": 181
    },
    {
      "kNumber": "K170191",
      "deviceName": "SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System",
      "productCode": "MCW",
      "decisionDate": "2017-06-16",
      "reviewDays": 144
    },
    {
      "kNumber": "K171427",
      "deviceName": "Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette",
      "productCode": "OTD",
      "decisionDate": "2017-06-13",
      "reviewDays": 29
    }
  ],
  "nameVariants": {
    "total": "8",
    "shown": [
      {
        "name": "MEDTRONIC VASCULAR",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Medtronic Vascular, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Medtronic%20Vascular%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Medtronic%20Vascular%22"
  },
  "provenance": [
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      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
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    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
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      "loadedAt": "2026-08-10T19:40:12Z",
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    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
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    },
    {
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      "loadedAt": "2026-08-10T19:40:11Z",
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    {
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      "loadedAt": "2026-08-10T07:06:24Z",
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  ],
  "retrievedAt": "2026-08-11T14:48:53.021Z"
}