Savion DLVR Guidewire, Savion FLX Guidewire

Savion DLVR Guidewire, Savion FLX Guidewire is an FDA 510(k)-cleared medical device (K180726) manufactured by Boston Scientific, Inc.. 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 17, 2018. Regulation: 8.