(132 days)
The Venture™ Wire Control Catheter is indicated for directing, steering, controlling, and supporting a guide wire to access discreet regions of the coronary and peripheral vasculature. It may also be used for manual delivery of saline solution or diagnostic contrast agents.
The Venture Wire Control Catheter is a single use, over-the-wire support catheter with a radiopaque tip that can be deflected continuously up to about 90° from the catheter axis. The device is compatible with all 0.014" guidewires. It is torqueable and can be use to guide the guidewire while in use as well as instantaneously shape, and control the curvature of the guidewire when needed. A luer attachment is also provided to allow for manual delivery of saline solution or diagnostic contrast agents through the guidewire lumen of the catheter.
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§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).