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The SoloPath® Re-Collapsible Access System is indicated for percutaneous insertion into the femoral artery over a guidewire and, once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. The device may also be used to expand femoroiliac artery lesions to facilitate its use as an Access System.

The SoloPath Re-Collapsible Access System is a sterile, single-use device that consists of a flexible, reinforced polymer sheath and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The SoloPath assembly is inserted percutaneously over a guidewire, with the deflated Expander in place. Once positioned into the vasculature and inflated with liquid, the Expander balloon exerts a controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The SoloPath Re-Collapsible Access System features an integrated external collapsible outer jacket which is pressurized with liquid under low pressure prior to removal, collapsing the outer sheath diameter for ease of removal. The Sheath is designed: 1) as a guide for catheters and/or devices introduced into the femoral artery and 2) to dilate stenosed femoro-iliac vessels as an adjunct to its primary function. The principles of operation for the subject SoloPath Re-Collapsible Access System are identical to those of the currently cleared SoloPath Re-Collapsible Access System (K121404). There are no changes to the insertion, deployment, or removal of the device as a result of this secondary indication.

The SoloPath® Re-Collapsible Access System is intended to be inserted percutaneously into the femoral artery, over a guidewire and once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery.

The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use. Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a large central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The Sheath is designed as a guide for catheters and/or devices introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal. The sheath is capable of expanding and actively collapsing.

The Onset Medical Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

The Onset Access Catheter System is a two-catheter system comprised of a Sheath and a Dilator. The Sheath has a distal region which expands when the Dilator is advanced. The Onset Access Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the Sheath and the Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the Sheath's distal expandable region into the catheter introducer sheath. The Catheter System is provided sterile, non-pyrogenic, and is intended for single use only.

The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

The SoloPath™ Balloon Expandable TransFemoral Introducer is an intravascular catheter introducer and is Intended for travel over a 0.038″ or smaller guidewire. The device includes a flexible Sheath composed of reinforced polymer that is compressed, folded and wrapped around a central, removable balloon dilatation catheter (the Expander). One radiopaque marker is located on the Sheath to indicate the end of the expandable portion of the Sheath. The Expander balloon is non-compliant and size limited. The Expander has both an inflation lumen and a guidewire lumen. The Expander is configured to be used with standard inflation devices having an appropriate pressure rating, a male Luer lock coupler, and a capacity of 25-CC. The Sheath is terminated, at its proximal end, by a hub having a straight through hemostasis port capable of accepting catheters equal to the full sheath inner diameter. An aspiration and infusion port, terminated with a 3-way stopcock, permits infusion of heparinized saline into the central port of the Sheath hub, prior to and during the procedure. The Expander incorporates a T connector, the through lumen port being terminated with a hemostasis valve for guidewire introduction, while the right angle port is for inflation of the Expander balloon. A separate aspiration and infusion side port, terminated with a 3-way stopcock, is also provided which permits fluid transfer into or from the guidewire lumen of the Expander.

The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

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The Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

Onset Expandable Transseptal Introducer (BETI)

The Onset Medical Pathway™ Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.

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The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a working channel, admitting access to the ureter by way of the urethra and bladder, during endoscopic urological procedures.

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