ISIGHT IMAGING CATHETER, MODEL 38986

ISIGHT IMAGING CATHETER, MODEL 38986 is an FDA 510(k)-cleared medical device (K060175) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 23, 2006. Regulation: 8.