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The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:

J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 3.0 mm J Tip.

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The Dual Stage Venous Return Cannula is indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery for up to six hours.

Dual Stage Venous Return Cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The devices are composed of the cannula: an open lumen PVC polymer tube incorporating wire reinforcement in distal section. In some models is present a malleable obturator inserted into the cannula to allow the placement of the cannula along the vein. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the venous line.

The distal end of the cannula has a lighthouse-shaped tip, allowing the venous blood to flow from the vessel into the cannula, in addition the distal sections of the cannula are perforated with multiple holes at multiple stages to better allow the fluid flows from outside into the cannula body. The clear proximal section is not reinforced to allow clamping; the proximal end typically does not have any pre-mounted connector and can accommodate a barbed connector for standard cardiopulmonary bypass tubing (½" diameter). In some models a pre-mounted 1/2" barbed connector is present.

The following cannula models are available:

The Dual Stage Venous Return Cannulae are the modified version of the disposables currently marketed under K943934.

Both modified and unmodified cannulae models are recommended for use as Venous cannula during cardiopulmonary bypass up to six hours.

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