CVIS INSIGHT IMAGING CATHETER

CVIS INSIGHT IMAGING CATHETER is an FDA 510(k)-cleared medical device (K924922) manufactured by Cardiovascular Imaging Systems, 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 June 28, 1993. Regulation: 8.