VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM

VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM is an FDA 510(k)-cleared medical device (K071554) manufactured by Volcano Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 2008. Regulation: 8.