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510(k) Data Aggregation

    K Number
    K092965
    Device Name
    TRAILRUNNER GUIDEWIRES
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2010-02-26

    (154 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires(Reference 510(k);s K970376, K041624)
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    K Number
    K082922
    Device Name
    FREEWAY AND RAILRUNNER GUIDEWIRES
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2008-12-09

    (69 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    These Freeway™ and Railrunner™ Guidewires are composed of two primary components: A PTFE coated stainless steel steerable core body, and a radiopaque platinum alloy distal coil. The coil is secured in its location by solder, which is attached to the core. The coil is attached to the core at the distal end, proximal end of the coil, and at a midpoint section (intermediate ioint). The product is offered with a shapeable straight tip or in a pre-shaped configuration. The Guidewires are optionally coated with MDX (silicone) over the distal tip and hydrophilic coating over portions of the distal tip of the Guidewire. The Guidewires are bound by the following parameters: Outside Diameter: .014", Lengths: 175cm - 300 cm, Tips: Straight or shaped, Flexibility: FREEWAY - 3 and 6 gm and RAILRUNNER - 9 and 12 gm distal loads.
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    K Number
    K081708
    Device Name
    TAXI ENDOSCOPIC GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2008-08-26

    (70 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Guidewire is intended for use in selective cannulation of the biliary ducts including, but not limited to the common bile, cystic, right and left hepatic ducts. The Endoscopic Guidewire is designed to be used during endoscopic biliary procedures for catheter introduction and exchanges of catheters, cannulas, and sphincterotomes.
    Device Description
    The Taxi® Endoscopic Guidewire is a dual colored, spiral patterned guidewire. The quidewire is composed of a Nitinol core with a dual colored PTFE jacket applied over the core to provide endoscopic visualization of wire movement. A polyurethane/lungsten loaded jacket encapsulates the distal end and ensures radiopacity. The distal tip of the guidewire is coated with hydrophilic coating.
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    K Number
    K080144
    Device Name
    MANDREL GUIDEWIRES OR M-WIRES
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2008-02-26

    (35 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    Nitinol or Stainless Steel core with Palladium coil secured to the ground, flexible (distal) end of the core. The core wire can be either uncoated or coated with PTFE (Polytetratlyoroethylene). Portions of the Guidewire can also be subsequently coated with silicone MDX4-4159 Fluid. The Guidewires are bound by the following parameters: Outside Diameter: .014" - .035" Lengths: Straight or shaped with various tip flexibilities. Tips: Coil Length: 2cm - 30 cm
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    K Number
    K073655
    Device Name
    PEGASUS STEERABLE (PTCA) GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2008-01-28

    (33 days)

    Product Code
    DQX, DOX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    The Pegasus 10 steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The wire employs a stainless steel proximal core shaft joined to a nitinol distal ground core portion. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire. The guidewires will be packaged in the standard Lake Region single pack packaging configuration (one wire in a dispenser, placed in a pouch, labeled and then placed in individual cartons). There will be no changes to the sterilization process for these guidewires.
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    K Number
    K060454
    Device Name
    TITAN GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2006-03-24

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    The Titan M steerable quidewires have a nominal diameter of 0.014" and nominal lengths of 185 cm and 300cm. The wire is configured with a radiopaque distal tip and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.
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    K Number
    K052347
    Device Name
    TITAN STEERABLE (PTCA) GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2006-02-17

    (172 days)

    Product Code
    DQX, DOX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    These steerable guidewires have a nominal diameter of 0.014" and nominal lengths of 180 cm and 300 cm. The wire is configured with a radiopaque gold cup at the distal end and an embedded magnet used with a navigation system to navigate the wire through vasculature. The distal tip can either be straight or angled. A hydrophilic coating covers the distal portion of the wire and a PTFE coating covers the proximal end of the wire.
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    K Number
    K042338
    Device Name
    CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2004-09-16

    (17 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.
    Device Description
    This device is a guidewire with a PTFE coated stainless steel core that has been ground at the distal end to provide the appropriate tip flexibility. The coils are joined to the core at the ground end and a distal tip coil is soldered to the core. The proximal PTFE coated portion of the core has two sections of the PTFE removed to aid in estimating guidewire positioning. The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are optionally coated with MDX (silicone). The guidewires are bound by the following parameters: Outside Diameter: .014" - .018", Lengths: 130cm - 300cm, Tips: Straight or shaped with various tip flexibilities.
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    K Number
    K041624
    Device Name
    PTCA STEERABLE HYDROPHILIC GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2004-07-16

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    Utilizing a proprietary process, LRM produces a PTFE coated stainless steel steerable core. The proximal portion of the core wire is coated with PTFE to provide lubricity and improve wire handling. A platinum alloy coil, placed within the confines of the outer coil and over-wrapping the distal core section, provides radiopacity in the distal tip. The coils are secured in their location by solder, which is attached to the core. The proximal end of the outer coil is attached to the core with braze, and the distal end has a mid-point of the outer coil which is attached to the core with solder (applicable designs). The product is offered with a shapeable straight tip or in a preshaped configuration. The guidewires are coated with MDX (silicone) or with hydrophilic coating. The guidewires are bound by the following parameters: Outside Diameter: .014", Lengths: 175cm - 300cm, Tips: Straight or shaped with various tip flexibilities, Flexibility: Floppy to Extra Support.
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    K Number
    K040825
    Device Name
    LAKE REGION HYDROPHILIC GUIDEWIRE
    Manufacturer
    LAKE REGION MFG., INC.
    Date Cleared
    2004-05-17

    (48 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAKE REGION MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.
    Device Description
    The Lake Region Hydrophilic Guidewire consists of a flexible, tapered core wire that decreases in outer diameter from the proximal to the distal end. The hydrophilic coating reduces friction during use. The radiopaque distal coil facilitates fluoroscopic visualization. The Lake Region Hydrophilic Guidewire will be available in two configuration, with either an outer diameter of 0.010" or 0.014" and 180cm long.
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