{
  "companyId": "52842",
  "slug": "datascope-corp-52842",
  "name": "Datascope Corp.",
  "clearances": {
    "total": 136,
    "last12Months": 0,
    "first": "1976-10-20",
    "latest": "2019-12-26"
  },
  "medianReviewDays": 90,
  "productCodeCount": 34,
  "recalls": {
    "total": 155,
    "openLast12Months": 7,
    "recent": [
      {
        "resNumber": "Z-1587-2026",
        "productCode": "DSP",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "initiated": "2026-02-06",
        "reason": "The Battery Charging Station is an optional dual-bay\ncharger used to charge the Cardiosave IABP Lithium-\nIon batteries when they are not being used to\noperate the IABP. Getinge has identified that a\nprotruding screw in the left battery bay limits full\ninsertion of certain batteries and prevents proper\ncharging. The right bay of the Battery Charging\nStation is not affected by this issue."
      },
      {
        "resNumber": "Z-1486-2026",
        "productCode": "DSP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-01-23",
        "reason": "The firm has identified that the battery runtime and cycle specifications contained in the devices  Instructions for Use (IFU) need to be updated."
      },
      {
        "resNumber": "Z-1487-2026",
        "productCode": "DSP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-01-23",
        "reason": "The firm has identified that the battery runtime and cycle specifications contained in the devices  Instructions for Use (IFU) need to be updated."
      },
      {
        "resNumber": "Z-0916-2026",
        "productCode": "DSP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-11-04",
        "reason": "The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023."
      },
      {
        "resNumber": "Z-0917-2026",
        "productCode": "DSP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-11-04",
        "reason": "The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023."
      }
    ]
  },
  "registration": {
    "sites": 3,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DSP",
      "deviceName": "System, Balloon, Intra-Aortic And Control",
      "clearances": 64,
      "latest": "2018-05-31",
      "medianReviewDays": 95
    },
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
      "clearances": 10,
      "latest": "2000-05-12",
      "medianReviewDays": 74
    },
    {
      "code": "DRT",
      "deviceName": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)",
      "clearances": 7,
      "latest": "1998-06-26",
      "medianReviewDays": 22
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 5,
      "latest": "2000-08-25",
      "medianReviewDays": 85
    },
    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
      "clearances": 4,
      "latest": "1999-05-13",
      "medianReviewDays": 143
    },
    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
      "clearances": 4,
      "latest": "2007-02-05",
      "medianReviewDays": 126
    },
    {
      "code": "CCK",
      "deviceName": "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase",
      "clearances": 3,
      "latest": "1992-10-14",
      "medianReviewDays": 151
    },
    {
      "code": "DSI",
      "deviceName": "Detector And Alarm, Arrhythmia",
      "clearances": 3,
      "latest": "2007-09-25",
      "medianReviewDays": 87
    },
    {
      "code": "MWI",
      "deviceName": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
      "clearances": 3,
      "latest": "2005-08-12",
      "medianReviewDays": 30
    },
    {
      "code": "CBQ",
      "deviceName": "Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)",
      "clearances": 2,
      "latest": "1993-08-25",
      "medianReviewDays": 146
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 2,
      "latest": "1997-09-25",
      "medianReviewDays": 96
    },
    {
      "code": "DSF",
      "deviceName": "Recorder, Paper Chart",
      "clearances": 2,
      "latest": "1977-11-22",
      "medianReviewDays": 22
    },
    {
      "code": "DXG",
      "deviceName": "Computer, Diagnostic, Pre-Programmed, Single-Function",
      "clearances": 2,
      "latest": "1988-08-19",
      "medianReviewDays": 130
    },
    {
      "code": "LDD",
      "deviceName": "Dc-Defibrillator, Low-Energy, (Including Paddles)",
      "clearances": 2,
      "latest": "1985-01-14",
      "medianReviewDays": 30
    },
    {
      "code": "BZK",
      "deviceName": "Spirometer, Monitoring (W/Wo Alarm)",
      "clearances": 1,
      "latest": "2006-11-02",
      "medianReviewDays": 49
    },
    {
      "code": "CBS",
      "deviceName": "Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)",
      "clearances": 1,
      "latest": "1998-03-13",
      "medianReviewDays": 72
    },
    {
      "code": "CCI",
      "deviceName": "Analyzer, Gas, Nitrogen, Gaseous-Phase",
      "clearances": 1,
      "latest": "1988-03-31",
      "medianReviewDays": 310
    },
    {
      "code": "CCL",
      "deviceName": "Analyzer, Gas, Oxygen, Gaseous-Phase",
      "clearances": 1,
      "latest": "1988-09-12",
      "medianReviewDays": 41
    },
    {
      "code": "DPT",
      "deviceName": "Probe, Blood-Flow, Extravascular",
      "clearances": 1,
      "latest": "1988-06-01",
      "medianReviewDays": 232
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 1,
      "latest": "1983-10-19",
      "medianReviewDays": 92
    },
    {
      "code": "DQR",
      "deviceName": "Cannula, Catheter",
      "clearances": 1,
      "latest": "1991-01-16",
      "medianReviewDays": 212
    },
    {
      "code": "DQY",
      "deviceName": "Catheter, Percutaneous",
      "clearances": 1,
      "latest": "1991-06-25",
      "medianReviewDays": 166
    },
    {
      "code": "DRE",
      "deviceName": "Dilator, Vessel, For Percutaneous Catheterization",
      "clearances": 1,
      "latest": "1990-12-10",
      "medianReviewDays": 70
    },
    {
      "code": "DRQ",
      "deviceName": "Amplifier And Signal Conditioner, Transducer Signal",
      "clearances": 1,
      "latest": "1976-11-15",
      "medianReviewDays": 5
    },
    {
      "code": "DRR",
      "deviceName": "Amplifier And Signal Conditioner, Biopotential",
      "clearances": 1,
      "latest": "1978-02-13",
      "medianReviewDays": 35
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "34",
  "recentClearances": [
    {
      "kNumber": "K190884",
      "deviceName": "TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool",
      "productCode": "GDW",
      "decisionDate": "2019-12-26",
      "reviewDays": 266
    },
    {
      "kNumber": "K181122",
      "deviceName": "CARDIOSAVE Intra-Aortic Balloon Pump",
      "productCode": "DSP",
      "decisionDate": "2018-05-31",
      "reviewDays": 31
    },
    {
      "kNumber": "K172305",
      "deviceName": "CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump",
      "productCode": "DSP",
      "decisionDate": "2017-10-12",
      "reviewDays": 73
    },
    {
      "kNumber": "K163542",
      "deviceName": "CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case",
      "productCode": "DSP",
      "decisionDate": "2017-01-31",
      "reviewDays": 46
    },
    {
      "kNumber": "K151254",
      "deviceName": "CARDIOSAVE Hybrid Intra-Aortic Balloon Pump",
      "productCode": "DSP",
      "decisionDate": "2015-07-02",
      "reviewDays": 51
    },
    {
      "kNumber": "K133074",
      "deviceName": "MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES",
      "productCode": "DSP",
      "decisionDate": "2013-12-12",
      "reviewDays": 73
    },
    {
      "kNumber": "K071805",
      "deviceName": "NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX",
      "productCode": "DSI",
      "decisionDate": "2007-09-25",
      "reviewDays": 85
    },
    {
      "kNumber": "K062569",
      "deviceName": "SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING",
      "productCode": "DXC",
      "decisionDate": "2007-02-14",
      "reviewDays": 167
    },
    {
      "kNumber": "K062098",
      "deviceName": "SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX",
      "productCode": "MHX",
      "decisionDate": "2007-02-05",
      "reviewDays": 196
    },
    {
      "kNumber": "K063525",
      "deviceName": "DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM",
      "productCode": "DSP",
      "decisionDate": "2007-01-05",
      "reviewDays": 44
    }
  ],
  "nameVariants": {
    "total": "8",
    "shown": [
      {
        "name": "Datascope Corp",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Datascope Corp",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datascope Corp.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Datascope Corp.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datascope Corp.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Datascope Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Datascope Corporation",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Datascope Corporation",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Datascope%20Corp.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Datascope%20Corp.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.035Z"
}