RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX is an FDA 510(k)-cleared medical device (K100892) 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 April 11, 2010. Regulation: 8.