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510(k) Data Aggregation

    K Number
    K111987
    Device Name
    FIBERNET EMBOLIC PROTECTION DEVICE
    Manufacturer
    LUMEN BIOMEDICAL, INC.
    Date Cleared
    2011-08-17

    (35 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0 mm.
    Device Description
    The FiberNet Embolic Protection System consists of a fiber filter on a 0.014" guide wire with attachable actuator tool and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer and a 40µm cell strainer cup.
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    K Number
    K082348
    Device Name
    FIBERNET EMBOLIC PROTECTION SYSTEM
    Manufacturer
    LUMEN BIOMEDICAL, INC.
    Date Cleared
    2008-11-18

    (95 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0mm.
    Device Description
    The system consists of a fiber filter on a 0.014" guidewire with attachable actuator tool (capture wire) and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529). System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40µm cell strainer cup.
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    K Number
    K080901
    Device Name
    LBI EMBOLECTOMY SYSTEM
    Manufacturer
    LUMEN BIOMEDICAL, INC.
    Date Cleared
    2008-10-02

    (185 days)

    Product Code
    QEW, DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
    Device Description
    The system consists of a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529) and a fiber element on a 0.014" guide wire with attachable actuator tool. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40um cell strainer cup.
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    K Number
    K071529
    Device Name
    XTRACT CATHETER SYSTEM
    Manufacturer
    LUMEN BIOMEDICAL, INC.
    Date Cleared
    2007-08-10

    (66 days)

    Product Code
    QEZ, DXE, OEZ
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xtract® Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
    Device Description
    The Xtract Catheter System consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40µm Strainer. The catheter is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub.
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    K Number
    K053372
    Device Name
    LBI CATHETER SYSTEM
    Manufacturer
    LUMEN BIOMEDICAL, INC.
    Date Cleared
    2006-06-30

    (207 days)

    Product Code
    QEZ, DXE, OEZ
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUMEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LBI Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
    Device Description
    The Lumen Biomedical Inc. (LBI) Xtract™ Catheter System is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter system. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub. The system consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40um Strainer.
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