Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 58115 - peripheral vascular guidewire - guide wires are intended to facilitate navigation across vascular anatomies and structures in order to deliver diagnostic and therapeutic devices. this guide wire is not intended for use in the central circulatory system.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 58115 - peripheral vascular guidewire - the hi-torque peripheral guide wires are intended to facilitate navigation across vascular anatomies and structures in order to deliver diagnostic and therapeutic devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 17846 - catheter, intravascular, guiding - the triclip steerable guide catheter(tsgc) is used to introduce the triclip delivery system(tcds) into the right side of the heart. the tsgc is also used to position and orient the tcds to the appropriate location above the tricuspid valve. the dilator is used for the introduction of the tsgc into the femoral vein and right atrium.the outer surface of the tsgc has a hydrophilic coating. the triclip? g4 system is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. the triclip device is indicated for patients with severe tricuspid regurgitation who are symptomatic despite medical therapy with valve anatomies that are conducive for transcatheter repair and who have been determined to be at high or greater estimated risk for tricuspid valve surgery by a heart team

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 58115 - peripheral vascular guidewire - peripheral guide wires are intended to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. intended for single use only. not intended for use in the coronary or cerebral vasculature.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 17846 - catheter, intravascular, guiding - the triclip steerable guide catheter (tsgc) is used to introduce the triclip delivery system (tcds) into the right side of the heart. the tsgc is also used to position and orient the tcds to the appropriate location above the tricuspid valve. the dilator is used for the introduction of the tsgc into the femoral vein and right atrium. the outer surface of the tsgc has a hydrophilic coating. the triclip system is intended for reconstruction of the insufficient tricuspid valve through tissue approximation in patients with severe or higher grade tricuspid regurgitation who are unsuitable for surgery and who have coaptation gaps less than or equal to 1 cm apart.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 47135 - intravascular catheter guidewire extension - a stiff but flexible wire used to extend a compatible vascular guidewire to facilitate the exchange of a catheter, or other interventional device, without exchanging the guidewire, and to maintain the intravascular position of the guidewire, during an interventional procedure in the coronary or peripheral arteries. it is joined to the proximal end of the guidewire with a compatible connector to create the extension. this is a single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 58865 - vascular introducer kit - a collection of sterile devices intended to be used for the percutaneous introduction of a guidewire and/or catheter into the vascular system for procedures that involve vascular access; it is not dedicated to a specific type of procedure. these are single-use devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 58865 - vascular introducer kit - a collection of sterile devices intended to be used for the percutaneous introduction of a guidewire and/or catheter into the vascular system for procedures that involve vascular access; it is not dedicated to a specific type of procedure. these are single-use devices.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 60466 - vascular graft implantation tool base - a reusable accessory is intended to be used only with the mitraclip system or triclip system product family during the mitraclip or triclip procedure.

Australia - English - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 57790 - mitral valve clip - the triclip g4 implant is a percutaneously implanted mechanical implant that grasps and coapts the tricuspid valve leaflets resulting in fixed approximation of the tricuspid leaflets throughout the cardiac cycle.the triclip g4 implant comes preloaded on a triclip delivery system (tcds).the tcds is used to advance and manipulate the implant for proper positioning and placement on the tricuspid valve leaflets.the tcds has a hydrophilic coating and is designed to deploy the implant in multiple step the triclip? g4 system is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. the triclip device is indicated for patients with severe tricuspid regurgitation who are symptomatic despite medical therapy with valve anatomies that are conducive for transcatheter repair and who have been determined to be at high or greater estimated risk for tricuspid valve surgery by a heart team