{
  "code": "DQY",
  "deviceName": "Catheter, Percutaneous",
  "deviceClass": "II",
  "regulationNumber": "870.1250",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 891,
    "last12Months": 11
  },
  "adverseEvents": {
    "total": 9264,
    "last12Months": 1945
  },
  "reviewDays": {
    "median": 85,
    "sampleSize": 891
  },
  "recalls": {
    "total": 619,
    "recent": [
      {
        "resNumber": "Z-2377-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Arrow International, Inc., Division of Teleflex Medical Inc.",
        "firmAsPublished": "ARROW INTERNATIONAL, LLC",
        "reason": "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.",
        "initiated": "2026-04-21"
      },
      {
        "resNumber": "Z-0188-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "BALT USA, LLC",
        "firmAsPublished": "BALT USA, LLC",
        "reason": "Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.",
        "initiated": "2025-09-25"
      },
      {
        "resNumber": "Z-2426-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.  \nThis risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.",
        "initiated": "2025-07-29"
      },
      {
        "resNumber": "Z-2427-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.  \nThis risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.",
        "initiated": "2025-07-29"
      },
      {
        "resNumber": "Z-2428-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Boston Scientific Corporation",
        "firmAsPublished": "Boston Scientific Corporation",
        "reason": "Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress.  \nThis risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse.",
        "initiated": "2025-07-29"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261825",
      "deviceName": "Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter",
      "applicant": "Abbott",
      "company": "Abbott",
      "decisionDate": "2026-07-02",
      "dateReceived": "2026-06-02"
    },
    {
      "kNumber": "K261631",
      "deviceName": "Amplatzer TorqVue Exchange System",
      "applicant": "Abbott Medical",
      "company": "Abbott Medical",
      "decisionDate": "2026-06-17",
      "dateReceived": "2026-05-18"
    },
    {
      "kNumber": "K260289",
      "deviceName": "Perfect-O Ostial Positioning Catheter",
      "applicant": "Balosmark, Inc.",
      "company": "Balosmark, Inc.",
      "decisionDate": "2026-06-05",
      "dateReceived": "2026-01-29"
    },
    {
      "kNumber": "K260993",
      "deviceName": "Amplatzer TorqVue Delivery System",
      "applicant": "Abbott",
      "company": "Abbott",
      "decisionDate": "2026-04-24",
      "dateReceived": "2026-03-26"
    },
    {
      "kNumber": "K253361",
      "deviceName": "Teleport Glide Microcatheter",
      "applicant": "OrbusNeich Medical (Shenzhen) Co., Ltd.",
      "company": "OrbusNeich Medical (Shenzhen) Co., Ltd.",
      "decisionDate": "2026-04-10",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K260499",
      "deviceName": "Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80",
      "applicant": "ABBOTT MEDICAL",
      "company": "Abbott Medical",
      "decisionDate": "2026-03-13",
      "dateReceived": "2026-02-13"
    },
    {
      "kNumber": "K253409",
      "deviceName": "C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K252417",
      "deviceName": "Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)",
      "applicant": "ABBOTT MEDICAL",
      "company": "Abbott Medical",
      "decisionDate": "2025-12-17",
      "dateReceived": "2025-08-01"
    },
    {
      "kNumber": "K252390",
      "deviceName": "Telescope Guide Extension Catheter",
      "applicant": "Medtronic, Ireland",
      "company": "Medtronic, Ireland",
      "decisionDate": "2025-10-29",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K251277",
      "deviceName": "CoraForce Microcatheter, CoraFlex Microcatheter",
      "applicant": "Reflow Medical, Inc.",
      "company": "Reflow Medical",
      "decisionDate": "2025-08-22",
      "dateReceived": "2025-04-24"
    }
  ],
  "topApplicants": [
    {
      "name": "Medtronic Vascular",
      "count": 31
    },
    {
      "name": "Biotronik, Inc.",
      "count": 23
    },
    {
      "name": "Cordis Corp.",
      "count": 21
    },
    {
      "name": "Vascular Solutions, Inc.",
      "count": 21
    },
    {
      "name": "Cook, Inc.",
      "count": 20
    }
  ],
  "topCompanies": [
    {
      "name": "Medtronic Vascular",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Boston Scientific Corporation",
      "count": 30,
      "spellings": 3
    },
    {
      "name": "Vascular Solutions, Inc.",
      "count": 27,
      "spellings": 2
    },
    {
      "name": "BIOTRONIK, Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Cook Incorporated",
      "count": 22,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Balosmark, Inc.",
      "since": "2026-06-05",
      "kNumber": "K260289"
    },
    {
      "name": "Abbott",
      "since": "2026-04-24",
      "kNumber": "K260993"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 207,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 208,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 305,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 249,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 234,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 287,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 226,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 231,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 224,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 248,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 256,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 276,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 311,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 307,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 233,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 272,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 261,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 259,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 237,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 263,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 267,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 225,
        "expectedLow": 177.9477749321742,
        "expectedHigh": 297.5228849558885,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 243,
        "expectedLow": 150.3668692358708,
        "expectedHigh": 257.4066759716056,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 218,
        "expectedLow": 179.6258096461058,
        "expectedHigh": 303.6576138963526,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 319,
        "expectedLow": 179.30065816479635,
        "expectedHigh": 306.58526097964665,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 249,
        "expectedLow": 189.54875330916886,
        "expectedHigh": 308.17069717711746,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 254,
        "expectedLow": 200.0927749411634,
        "expectedHigh": 314.82901675798036,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 275,
        "expectedLow": 312.0529743547179,
        "expectedHigh": 494.03882458533343,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 224,
        "expectedLow": 192.6690402911223,
        "expectedHigh": 358.2504282943855,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 258,
        "expectedLow": 179.96885423650087,
        "expectedHigh": 367.581937233959,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 205,
        "expectedLow": 171.45010764740823,
        "expectedHigh": 361.90155973889114,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 233,
        "expectedLow": 130.03360530266474,
        "expectedHigh": 318.46423294293925,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 281,
        "expectedLow": 146.27972876293074,
        "expectedHigh": 356.3882854419432,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 226,
        "expectedLow": 178.9812598124644,
        "expectedHigh": 421.0089436931857,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 276,
        "expectedLow": 123.09388307462905,
        "expectedHigh": 348.66779687233685,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 311,
        "expectedLow": 154.98823499882323,
        "expectedHigh": 386.6046103166167,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DQY (Catheter, Percutaneous) has three findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class I) (Z-2377-2026, Z-0188-2026). 2 first-time filers in the last 12 months, Balosmark, Inc. and Abbott (K260289, K260993). The code is crowded, scoring 89 of 100 — 253 companies hold a clearance here and 11 arrived in the last 12 months (DQY:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class I)",
        "recordIds": [
          "Z-2377-2026",
          "Z-0188-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Balosmark, Inc. and Abbott",
        "recordIds": [
          "K260289",
          "K260993"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 89 of 100 — 253 companies hold a clearance here and 11 arrived in the last 12 months",
        "recordIds": [
          "DQY:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3ADQY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADQY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADQY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADQY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADQY"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.679Z"
}