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510(k) Data Aggregation

    K Number
    K242824
    Device Name
    PTFE Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2024-12-06

    (79 days)

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

    Lake Region Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.
    Device Description
    PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use. The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire. The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.
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    K Number
    K221575
    Device Name
    Pre-Formed Blue
    Manufacturer
    Lake Region Medical
    Date Cleared
    2022-10-07

    (128 days)

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

    Lake Region Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Formed Blue guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.
    Device Description
    The Pre-Formed Blue guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use. The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil component is fitted over the distal end of the core and is a stainless-steel coiled wire coated with blue PTFE coating. The coil and core components are secured together using a weld on the distal end, forming the guidewire. The pre-shaped distal end of the guidewire is available in two sizes (extra-small and small). The Pre-Formed Blue guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Blue guidewire.
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    K Number
    K211741
    Device Name
    Pre-Formed Extra Support Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2021-11-22

    (168 days)

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

    Lake Region Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.
    Device Description
    The Pre-Formed Guidewire Extra Support guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use. The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The proximal end of the core wire is coated with grev polytetrafluoroethylene (PTFE) coating. The coil component is fitted over the distal end of the core and is a stainless-steel coiled with green PTFE coating. The coil and core components are secured together using a weld on the distal and a glue joint at the proximal end of the coil, forming the guidewire. The pre-shaped distal end of the guidewire is available in three sizes (extra-small, small and large). The Pre-Formed Extra Support guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Extra Support guidewire.
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    K Number
    K182457
    Device Name
    Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
    Manufacturer
    Brivant Limited (Lake Region Medical)
    Date Cleared
    2019-04-18

    (223 days)

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

    Brivant Limited (Lake Region Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
    Device Description
    The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity). The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity. Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long. When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA). Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.
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    K Number
    K160643
    Device Name
    ENROUTE 0.014 Guidewire
    Manufacturer
    LAKE REGION MEDICAL
    Date Cleared
    2016-10-18

    (225 days)

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

    LAKE REGION MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENROUTE 0.014" Guidewire is intended for use in the peripheral vasculature.
    Device Description
    The ENROUTE .014” guidewire is a disposable medical device designed for single use only. It consists of a 95cm PTFE coated 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over approximately 9.5cm in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product an area of reduced stiffness. The very distal tip section is flattened to further reduce stiffness and enable the tip to be shaped. The distal section is covered with a 5cm platinum tungsten spring coil. This provides for greater visibility on x-ray equipment (radiopacity). A hydrophilic coating is applied to the distal section to enhance lubricity. The product is available in straight configuration
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    K Number
    K151244
    Device Name
    Pre-Formed Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2015-06-11

    (31 days)

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

    Lake Region Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.
    Device Description
    The 0.035" diameter, 260-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are manufactured from Stainless Steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE), The coil and the core components are welded together on the distal and proximal ends, forming the guidewire. The distal ends are shaped into a double-curve.
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    K Number
    K140536
    Device Name
    HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
    Manufacturer
    LAKE REGION MEDICAL
    Date Cleared
    2014-12-17

    (288 days)

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

    LAKE REGION MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hi-Torque guide wires are indicated to facilitate the placement of percutaneous devices during Percutaneous Transluminal Angioplasty (PTA) in peripheral arteries such as femoral, poplited anteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.
    Device Description
    The Hi-Torque Connect guidewire range are disposable medical devices designed for single use only. They consist of a PTFE coated 0.018" diameter stainless steel core wire, one end of which is reduced in diameter in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and is varied to produce 3 unique levels of support. Each of these 3 levels of support are provided in 3 different length options (145cm - 300cm)
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    K Number
    K142393
    Device Name
    PREDICATE III GUIDEWIRE
    Manufacturer
    LAKE REGION MEDICAL
    Date Cleared
    2014-11-25

    (90 days)

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

    LAKE REGION MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.
    Device Description
    The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers.
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    K Number
    K142397
    Device Name
    Predicate III Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2014-09-19

    (23 days)

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

    Lake Region Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
    Device Description
    The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers. The PREDICATE™ III GUIDEWIRE family is bound by the following parameters: Lengths: 30cm – 500cm, Outside Diameter: 0.018" to 0.038", Tips: Straight or Shaped with various flexibilities, Coil Length: Full length, 2cm to 30cm.
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    K Number
    K140482
    Device Name
    MANDREL GUIDEWIRE
    Manufacturer
    LAKE REGION MEDICAL
    Date Cleared
    2014-04-08

    (41 days)

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

    LAKE REGION MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.
    Device Description
    The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers. The Mandrel guidewire family is bound by the following parameters: Lengths: 20cm to 500cm, Outside Diameter: 0.014" To 0.35", Tips: Straight or shaped with various flexibilities, Coil Length: 2cm to 30cm.
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