Fathom-16 Steerable Guidewires

Fathom-16 Steerable Guidewires is an FDA 510(k)-cleared medical device (K170636) manufactured by Boston Scientific Corporation. 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 21, 2017. Regulation: 8.