FDAnews Device Daily Bulletin

Vascular Solutions Gains 510(k) Clearance for Fluent Inflation Device

Oct. 24, 2016

Vascular Solutions has received 510(k) clearance from the FDA for the Fluent inflation device for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters.

The device features a 25cc barrel and creates pressures up to 30 atmospheres of mercury (atm). The design provides a system that is easy to fill, flush, and operate.  The locking mechanism is marked to show locked and unlocked positions.  The pressure gauge glows in the dark so that it is easily readable under low light conditions in the catheter lab.

Vascular Solutions expects to launch the device in the U.S. and Europe during the fourth quarter. — Cynthia Jessup

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