{
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        "initiated": "2020-08-31",
        "reason": "The inner lumen of the Langston catheter may separate from the hub during pressure injection."
      },
      {
        "resNumber": "Z-0111-2021",
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      },
      {
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      {
        "resNumber": "Z-0113-2021",
        "productCode": "DQO",
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        "reason": "The inner lumen of the Langston catheter may separate from the hub during pressure injection."
      },
      {
        "resNumber": "Z-1747-2020",
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        "reason": "The inner lumen of the Langston catheter may separate from the hub during pressure injection."
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    {
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    {
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      "deviceName": "Powered Laser Surgical Instrument",
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    {
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    {
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    {
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    {
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    {
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    {
      "code": "DTL",
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    {
      "code": "FMI",
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    {
      "code": "KHJ",
      "deviceName": "Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)",
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    {
      "code": "LOX",
      "deviceName": "Catheters, Transluminal Coronary Angioplasty, Percutaneous",
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    {
      "code": "MMX",
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      "deviceName": "Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58",
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      },
      {
        "name": "Vascular Solutions, Inc.",
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      {
        "name": "Vascular Solutions, Inc.",
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      {
        "name": "Vascular Solutions, LLC",
        "dataset": "device/510k",
        "method": "normalised"
      }
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  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Vascular%20Solutions%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Vascular%20Solutions%2C%20Inc.%22"
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  "retrievedAt": "2026-08-11T14:48:53.039Z"
}
