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510(k) Data Aggregation

    K Number
    K182232
    Device Name
    Octane Mechanical Thrombectomy System
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2018-09-11

    (25 days)

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

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Octane Mechanical Thrombectomy System is intended for the removal/aspiration of embolic material (thrombus/ debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.
    Device Description
    The Octane Mechanical Thrombectomy System consists of two components: the Octane mechanical thrombectomy catheter and the Octane hand pump. The Octane mechanical thrombectomy catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The rapid exchange guidewire lumen is compatible with guidewires ≤ 0.018" in diameter and the 6F inner catheter lumen is compatible with guidewires ≤ 0.038" in diameter. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane mechanical thrombectomy catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane mechanical thrombectomy catheter hub. The Octane Mechanical Thrombectomy System has been sterilized with ethylene oxide.
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    K Number
    K181647
    Device Name
    Bandit guidewire
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2018-07-20

    (28 days)

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

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
    Device Description
    The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
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    K Number
    K180913
    Device Name
    VSI Micro-Introducer Kit
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2018-05-09

    (30 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VSI Micro-Introducer Kits are intended for use in percutaneous introduction of up to a 0.018 inch guidewire or catheter into the vascular system following a small gauge needle stick.
    Device Description
    The VSI micro-introducer kits consist of a sheath and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 2.3 F, 4 F or 5 F outer diameter (O.D.) and with a straight or angled tip. The dilator is available with regular flexibility or in a 'stiffen' version. The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shaft contains a stainless steel hypotube.
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    K Number
    K180088
    Device Name
    TrapLiner catheter
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2018-04-04

    (82 days)

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

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature.
    Device Description
    The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon.
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    K Number
    K173891
    Device Name
    Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2018-01-19

    (29 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.
    Device Description
    The Gel-Bead embolization spheres product consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains either 1 ml or 2 ml of spheres suspended in 5 ml or 4 ml of saline, respectively. Offered in five nominal size ranges (100-300 µm, 500-700 µm, 600-800 µm, and 700-1000 um), the spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.
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    K Number
    K173532
    Device Name
    Raider Guidewire
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2017-12-15

    (30 days)

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

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
    Device Description
    The Raider guidewire is a stainless steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 190 cm and 300 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
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    K Number
    K170544
    Device Name
    Langston dual lumen catheter
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2017-11-17

    (266 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.
    Device Description
    The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.
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    K Number
    K171946
    Device Name
    Gel-Bead
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2017-10-25

    (118 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gel-bead embolization spheres are intended for use in embolization of hypervascular tumors.
    Device Description
    The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres prefilled in a 20 ml syringe. The syringe contains 2 ml of spheres suspended in 4 ml of saline. Gel-Bead is offered in four nominal size ranges: 100-300 um, 300-500 um, 500-700 um and 700-1000 um. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.
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    K Number
    K172090
    Device Name
    GuideLiner V3 Catheter
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2017-10-20

    (101 days)

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

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
    Device Description
    The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes – 5F, 5.5F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semi-circular polymer that meets the proximal end of the full-round guide extension segment. The GuideLiner V3 catheter has two platinumiridium marker bands; the distal marker band is located at the distal tip and the proximal marker band is located near the collar. The GuideLiner V3 catheter also has two positioning marks located 95 cm (single mark) and 105 cm (double mark) from the distal tip.
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    K Number
    K171335
    Device Name
    Venture 038 catheter
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2017-06-07

    (30 days)

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

    Vascular Solutions, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venture 038 catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
    Device Description
    The Venture 038 catheter is an over-the-wire single lumen catheter with a radiopaque deflectable distal tip. The deflectable distal tip is actuated by rotating a knob on the control handle of the proximal end of the catheter. The Venture 038 catheter has a working length of 120 cm or 70 cm and has a hydrophilic coating on the distal 45 cm of the catheter. The Venture 038 catheter provides support to 0.035" guidewires and is compatible with 6F introducer sheaths and 8F guide catheters.
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