REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is an FDA 510(k)-cleared medical device (K160583) 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 October 25, 2016. Regulation: 8.