CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE is an FDA 510(k)-cleared medical device (K921147) manufactured by Cardiovascular Imaging Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 1992. Regulation: 8.