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510(k) Data Aggregation

    K Number
    K210419
    Device Name
    BIOTEQ Drainage Catheter BT-PDS-series
    Manufacturer
    Bioteque Corporation
    Date Cleared
    2022-04-13

    (426 days)

    Product Code
    FGE, GBO, LJE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioteque Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOTEQ Drainage Catheter Set (Seldinger Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders nephrostomy, urinary and other fluids.
    Device Description
    The BIOTEO Drainage Catheter Set (Seldinger Type), BT-PDS-series percutaneous drainage catheter with hydrophilic coating, are percutaneous drainage catheters used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a pigtail or close loop and drainage holes. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator should use Seldinger Technique to provide access.
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    K Number
    K200103
    Device Name
    BIOTEQ Drainage Catheter Set (One Step Type)
    Manufacturer
    Bioteque Corporation
    Date Cleared
    2020-10-09

    (266 days)

    Product Code
    FGE, GBO, LHI, NEP
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioteque Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.
    Device Description
    The BIOTEQ Drainage Catheter Set (One Step Type), BT-PD1-series percutaneous drainage catheter with hydrophilic coating, is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a "J", a pigtail or close loop and drainage holes. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either Direct Access Technique or Seldinger Technique to provide access.
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