FATHOM (TM) 14 STEERABLE GUIDEWIRE

FATHOM (TM) 14 STEERABLE GUIDEWIRE is an FDA 510(k)-cleared medical device (K111498) 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 June 29, 2011. Regulation: 8.