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The SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

The SafeCross Vascular Introducer System is used to introduce various cardiovascular catheters into the vasculature including the heart. Unlike the predicate device, it does not include an RF Puncture Member and is not intended to cross the atrial septum. The subject device system includes three (3) components: the Steerable Introducer Sheath (SIS), a Long Access Dilator (LAD), and a Short Access Dilator (SAD). In the subject device, the SIS and LAD are identical to their respective corresponding components of the predicate device (K203459). The Vascular SIS features a compliant, specially shaped, atraumatic overhanging Positioning Balloon on its distal end to facilitate the accurate positioning and stability of the SIS while navigating the patient's vasculature. The physician is able to bi-directionally deflect the distal segment in a range of 0° to 180°. The subject device includes a new component, the SAD (12 Fr, 20 cm in length).