INTRAVASCULAR IMAGING SYSTEM/MODIFIED

INTRAVASCULAR IMAGING SYSTEM/MODIFIED is an FDA 510(k)-cleared medical device (K910281) manufactured by Intertherapy, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 1991. Regulation: 8.